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Trial record 76 of 325 for:    "Acute Lymphocytic Leukemia" | "Methotrexate"

Clofarabine and Cytarabine in Treating Young Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00372619
Recruitment Status : Completed
First Posted : September 7, 2006
Results First Posted : February 3, 2014
Last Update Posted : June 5, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia
Interventions Drug: clofarabine
Drug: cytarabine
Drug: methotrexate
Other: laboratory biomarker analysis
Enrollment 74
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients. Clofarabine 40 mg/m² to Assess Feasibility in AML Patients. Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients. Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients. Clofarabine 52 mg/m² to Assess Feasibility in AML Patients. Clofarabine 52 mg/m² to Assess Efficacy in AML Patients Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt
Hide Arm/Group Description

Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Period Title: Overall Study
Started 8 2 3 10 7 42 2
Completed 8 2 3 10 7 39 2
Not Completed 0 0 0 0 0 3 0
Reason Not Completed
Ineligible             0             0             0             0             0             2             0
Inevaluable             0             0             0             0             0             1             0
Arm/Group Title Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients. Clofarabine 40 mg/m² to Assess Feasibility in AML Patients. Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients. Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients. Clofarabine 52 mg/m² to Assess Feasibility in AML Patients. Clofarabine 52 mg/m² to Assess Efficacy in AML Patients Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt Total
Hide Arm/Group Description

Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Total of all reporting groups
Overall Number of Baseline Participants 8 2 3 10 7 42 2 74
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 2 participants 3 participants 10 participants 7 participants 42 participants 2 participants 74 participants
<=18 years
7
  87.5%
1
  50.0%
3
 100.0%
9
  90.0%
7
 100.0%
34
  81.0%
1
  50.0%
62
  83.8%
Between 18 and 65 years
1
  12.5%
1
  50.0%
0
   0.0%
1
  10.0%
0
   0.0%
8
  19.0%
1
  50.0%
12
  16.2%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 2 participants 3 participants 10 participants 7 participants 42 participants 2 participants 74 participants
12.75  (6.37) 15.09  (6.33) 13.09  (1.54) 9.16  (6.69) 9.01  (5.79) 12.01  (7.12) 19.65  (1.80) 15.13  (5.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 2 participants 3 participants 10 participants 7 participants 42 participants 2 participants 74 participants
Female
5
  62.5%
0
   0.0%
2
  66.7%
4
  40.0%
3
  42.9%
20
  47.6%
1
  50.0%
35
  47.3%
Male
3
  37.5%
2
 100.0%
1
  33.3%
6
  60.0%
4
  57.1%
22
  52.4%
1
  50.0%
39
  52.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 2 participants 3 participants 10 participants 7 participants 42 participants 2 participants 74 participants
Hispanic or Latino
1
  12.5%
0
   0.0%
2
  66.7%
1
  10.0%
0
   0.0%
7
  16.7%
0
   0.0%
11
  14.9%
Not Hispanic or Latino
6
  75.0%
2
 100.0%
0
   0.0%
8
  80.0%
6
  85.7%
35
  83.3%
2
 100.0%
59
  79.7%
Unknown or Not Reported
1
  12.5%
0
   0.0%
1
  33.3%
1
  10.0%
1
  14.3%
0
   0.0%
0
   0.0%
4
   5.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 2 participants 3 participants 10 participants 7 participants 42 participants 2 participants 74 participants
American Indian or Alaska Native
0
   0.0%
1
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.4%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   4.8%
0
   0.0%
2
   2.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  12.5%
0
   0.0%
1
  33.3%
1
  10.0%
0
   0.0%
8
  19.0%
0
   0.0%
11
  14.9%
White
6
  75.0%
1
  50.0%
2
  66.7%
8
  80.0%
7
 100.0%
28
  66.7%
2
 100.0%
54
  73.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  12.5%
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
4
   9.5%
0
   0.0%
6
   8.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 2 participants 3 participants 10 participants 7 participants 42 participants 2 participants 74 participants
United States 7 1 3 8 7 37 2 65
Canada 1 1 0 2 0 5 0 9
1.Primary Outcome
Title Overall Response (CR for ALL Patients), (CR + CRp for AML Patients)
Hide Description

Overall response for ALL patients: CR - complete remission (attainment of an M1 bone marrow (< 5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (absolute neutrophil count (ANC) > 750/μL and platelet count > 75,000/μL).

Overall response for AML patients: (CR + CRp), defined as:

CR - complete remission (attainment of an M1 bone marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral blood counts (absolute neutrophil count (ANC) > 1000/uL and platelet count > 100,000/uL)) or CRp - remission without platelet recovery (Attainment of an M1 bone marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of absolute neutrophil count (ANC) > 1000/uL and platelet transfusion independence (defined as: no platelet transfusions x 1 week)).

Time Frame 2 cycles or up to 84 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients. Clofarabine 40 mg/m² to Assess Feasibility in AML Patients. Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients. Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients. Clofarabine 52 mg/m² to Assess Feasibility in AML Patients. Clofarabine 52 mg/m² to Assess Efficacy in AML Patients Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt
Hide Arm/Group Description:

Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Overall Number of Participants Analyzed 8 2 3 10 7 39 2
Measure Type: Number
Unit of Measure: participants
1 2 0 2 2 19 2
2.Secondary Outcome
Title Safety and Tolerability as Measured by CTCAE v3.0
Hide Description Number of participants with at least one grade 3 or higher adverse event during therapy.
Time Frame End of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Ineligible (n=2) and inevaluable (n=1) patients are excluded
Arm/Group Title Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients. Clofarabine 40 mg/m² to Assess Feasibility in AML Patients. Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients. Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients. Clofarabine 52 mg/m² to Assess Feasibility in AML Patients. Clofarabine 52 mg/m² to Assess Efficacy in AML Patients Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt
Hide Arm/Group Description:

Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Overall Number of Participants Analyzed 8 2 3 10 7 39 2
Measure Type: Number
Unit of Measure: number participants
7 2 3 10 7 35 2
3.Secondary Outcome
Title Correlate the Expression of Apoptosis Specific Genes
Hide Description Correlate the expression of apoptosis specific genes with chemoresistance and determine whether therapy with clofarabine is able to overcome blocks in apoptosis through modulation of gene expression. Gene expression analysis will be performed on specimens obtained during therapy. Apoptosis specific microarray data will be analyzed using GeneTraffic software (Iobion Informatics, La Jolla CA).
Time Frame End of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was not completed, because the tissue microarray was unsuccessful.
Arm/Group Title Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients. Clofarabine 40 mg/m² to Assess Feasibility in AML Patients. Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients. Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients. Clofarabine 52 mg/m² to Assess Feasibility in AML Patients. Clofarabine 52 mg/m² to Assess Efficacy in AML Patients Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt
Hide Arm/Group Description:

Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Overall Number of Participants Analyzed 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description There are n=42 pts enrolled to group Clofarabine 52 mg/m² to Assess Efficacy in AML Patients, 2 pts ineligible & 1 inevaluable for response. For toxicity, ineligible pts are excluded, but the inevaluable pt is included for analysis of toxicity resulting in n=40. OM #2 reports the number of pts having at least 1, gr 3 or higher AE during therapy. Pts with SAEs are not determined by this definition, but by whether a pt had at least 1 reportable AE requiring an AdEERs report during therapy.
 
Arm/Group Title Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients. Clofarabine 40 mg/m² to Assess Feasibility in AML Patients. Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients. Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients. Clofarabine 52 mg/m² to Assess Feasibility in AML Patients. Clofarabine 52 mg/m² to Assess Efficacy in AML Patients Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt
Hide Arm/Group Description

Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.

clofarabine: Given IV for 5 days

cytarabine: Given IV

methotrexate: Given intrathecally or IT age based dosage

laboratory biomarker analysis

All-Cause Mortality
Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients. Clofarabine 40 mg/m² to Assess Feasibility in AML Patients. Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients. Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients. Clofarabine 52 mg/m² to Assess Feasibility in AML Patients. Clofarabine 52 mg/m² to Assess Efficacy in AML Patients Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients. Clofarabine 40 mg/m² to Assess Feasibility in AML Patients. Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients. Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients. Clofarabine 52 mg/m² to Assess Feasibility in AML Patients. Clofarabine 52 mg/m² to Assess Efficacy in AML Patients Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/8 (62.50%)   2/2 (100.00%)   2/3 (66.67%)   7/10 (70.00%)   3/7 (42.86%)   14/40 (35.00%)   2/2 (100.00%) 
Blood and lymphatic system disorders               
Febrile neutropenia  2/8 (25.00%)  1/2 (50.00%)  0/3 (0.00%)  1/10 (10.00%)  1/7 (14.29%)  6/40 (15.00%)  0/2 (0.00%) 
Cardiac disorders               
Left ventricular systolic dysfunction  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Right ventricular dysfunction  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Sinus tachycardia  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  1/7 (14.29%)  0/40 (0.00%)  0/2 (0.00%) 
Gastrointestinal disorders               
Abdominal pain  2/8 (25.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Colitis  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Diarrhea  2/8 (25.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Ileus  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Nausea  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Pancreatitis  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Small intestinal mucositis  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Vomiting  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
General disorders               
Chills  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  1/7 (14.29%)  0/40 (0.00%)  0/2 (0.00%) 
Fatigue  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  1/7 (14.29%)  0/40 (0.00%)  0/2 (0.00%) 
Non-cardiac chest pain  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Infections and infestations               
Bladder infection  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Infections and infestations - Other  4/8 (50.00%)  0/2 (0.00%)  1/3 (33.33%)  3/10 (30.00%)  2/7 (28.57%)  8/40 (20.00%)  0/2 (0.00%) 
Sepsis  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Investigations               
Alanine aminotransferase increased  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Aspartate aminotransferase increased  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  2/10 (20.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Blood bilirubin increased  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Fibrinogen decreased  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
GGT increased  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Lipase increased  1/8 (12.50%)  0/2 (0.00%)  1/3 (33.33%)  0/10 (0.00%)  0/7 (0.00%)  3/40 (7.50%)  1/2 (50.00%) 
Serum amylase increased  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  2/40 (5.00%)  0/2 (0.00%) 
Metabolism and nutrition disorders               
Anorexia  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Hypercalcemia  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  2/40 (5.00%)  1/2 (50.00%) 
Hyperglycemia  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  1/2 (50.00%) 
Hypermagnesemia  0/8 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Hypoalbuminemia  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  1/2 (50.00%) 
Hypokalemia  2/8 (25.00%)  1/2 (50.00%)  0/3 (0.00%)  2/10 (20.00%)  0/7 (0.00%)  2/40 (5.00%)  0/2 (0.00%) 
Hyponatremia  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  1/2 (50.00%) 
Hypophosphatemia  0/8 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Tumor lysis syndrome  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Musculoskeletal and connective tissue disorders               
Back pain  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Bone pain  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Chest wall pain  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Nervous system disorders               
Headache  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Neuralgia  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Peripheral motor neuropathy  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Peripheral sensory neuropathy  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Renal and urinary disorders               
Proteinuria  0/8 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Cough  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Dyspnea  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Hypoxia  2/8 (25.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  2/40 (5.00%)  0/2 (0.00%) 
Pneumonitis  2/8 (25.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Skin and subcutaneous tissue disorders               
Alopecia  0/8 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Palmar-plantar erythrodysesthesia syndrome  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Rash maculo-papular  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  1/7 (14.29%)  1/40 (2.50%)  0/2 (0.00%) 
Vascular disorders               
Capillary leak syndrome  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  0/7 (0.00%)  3/40 (7.50%)  0/2 (0.00%) 
Hypertension  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Hypotension  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  1/7 (14.29%)  2/40 (5.00%)  0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients. Clofarabine 40 mg/m² to Assess Feasibility in AML Patients. Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients. Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients. Clofarabine 52 mg/m² to Assess Feasibility in AML Patients. Clofarabine 52 mg/m² to Assess Efficacy in AML Patients Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/8 (100.00%)   2/2 (100.00%)   3/3 (100.00%)   10/10 (100.00%)   7/7 (100.00%)   38/40 (95.00%)   2/2 (100.00%) 
Blood and lymphatic system disorders               
Anemia  2/8 (25.00%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Blood and lymphatic system disorders - Other  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  1/7 (14.29%)  0/40 (0.00%)  0/2 (0.00%) 
Febrile neutropenia  3/8 (37.50%)  0/2 (0.00%)  1/3 (33.33%)  5/10 (50.00%)  4/7 (57.14%)  12/40 (30.00%)  0/2 (0.00%) 
Cardiac disorders               
Cardiac disorders - Other  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  2/7 (28.57%)  3/40 (7.50%)  0/2 (0.00%) 
Sinus tachycardia  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  1/7 (14.29%)  1/40 (2.50%)  0/2 (0.00%) 
Endocrine disorders               
Cushingoid  0/8 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Hyperthyroidism  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Eye disorders               
Conjunctivitis  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Dry eye  0/8 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Eye disorders - Other  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Eye pain  0/8 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  1/10 (10.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Keratitis  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Photophobia  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Watering eyes  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Gastrointestinal disorders               
Abdominal distension  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  1/7 (14.29%)  0/40 (0.00%)  0/2 (0.00%) 
Abdominal pain  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  3/10 (30.00%)  1/7 (14.29%)  3/40 (7.50%)  0/2 (0.00%) 
Cheilitis  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Constipation  1/8 (12.50%)  0/2 (0.00%)  1/3 (33.33%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  1/2 (50.00%) 
Diarrhea  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  2/10 (20.00%)  4/7 (57.14%)  10/40 (25.00%)  0/2 (0.00%) 
Dysphagia  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Esophagitis  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Gastritis  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  0/7 (0.00%)  2/40 (5.00%)  0/2 (0.00%) 
Mucositis oral  0/8 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  1/10 (10.00%)  1/7 (14.29%)  4/40 (10.00%)  0/2 (0.00%) 
Nausea  2/8 (25.00%)  1/2 (50.00%)  1/3 (33.33%)  4/10 (40.00%)  4/7 (57.14%)  10/40 (25.00%)  2/2 (100.00%) 
Rectal pain  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Toothache  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Typhlitis  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Upper gastrointestinal hemorrhage  0/8 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Vomiting  2/8 (25.00%)  0/2 (0.00%)  2/3 (66.67%)  4/10 (40.00%)  5/7 (71.43%)  9/40 (22.50%)  1/2 (50.00%) 
General disorders               
Chills  0/8 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Edema face  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Edema limbs  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Fatigue  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  2/40 (5.00%)  0/2 (0.00%) 
Fever  1/8 (12.50%)  0/2 (0.00%)  1/3 (33.33%)  3/10 (30.00%)  1/7 (14.29%)  5/40 (12.50%)  0/2 (0.00%) 
Non-cardiac chest pain  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Pain  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  1/7 (14.29%)  4/40 (10.00%)  0/2 (0.00%) 
Hepatobiliary disorders               
Hepatobiliary disorders - Other  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  2/40 (5.00%)  0/2 (0.00%) 
Immune system disorders               
Allergic reaction  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  2/40 (5.00%)  0/2 (0.00%) 
Anaphylaxis  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  1/7 (14.29%)  3/40 (7.50%)  0/2 (0.00%) 
Infections and infestations               
Catheter related infection  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  2/40 (5.00%)  0/2 (0.00%) 
Gum infection  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Hepatic infection  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Infections and infestations - Other  2/8 (25.00%)  2/2 (100.00%)  1/3 (33.33%)  2/10 (20.00%)  4/7 (57.14%)  17/40 (42.50%)  1/2 (50.00%) 
Lung infection  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Sepsis  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Skin infection  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  2/40 (5.00%)  0/2 (0.00%) 
Investigations               
Alanine aminotransferase increased  4/8 (50.00%)  2/2 (100.00%)  1/3 (33.33%)  4/10 (40.00%)  1/7 (14.29%)  14/40 (35.00%)  1/2 (50.00%) 
Alkaline phosphatase increased  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Aspartate aminotransferase increased  2/8 (25.00%)  0/2 (0.00%)  2/3 (66.67%)  5/10 (50.00%)  1/7 (14.29%)  10/40 (25.00%)  1/2 (50.00%) 
Blood bilirubin increased  2/8 (25.00%)  0/2 (0.00%)  0/3 (0.00%)  5/10 (50.00%)  0/7 (0.00%)  6/40 (15.00%)  0/2 (0.00%) 
Creatinine increased  0/8 (0.00%)  1/2 (50.00%)  1/3 (33.33%)  1/10 (10.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Electrocardiogram QT corrected interval prolonged  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  1/7 (14.29%)  3/40 (7.50%)  0/2 (0.00%) 
GGT increased  0/8 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/10 (0.00%)  0/7 (0.00%)  7/40 (17.50%)  0/2 (0.00%) 
INR increased  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Lipase increased  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Lymphocyte count decreased  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Neutrophil count decreased  2/8 (25.00%)  0/2 (0.00%)  0/3 (0.00%)  2/10 (20.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Platelet count decreased  3/8 (37.50%)  0/2 (0.00%)  0/3 (0.00%)  2/10 (20.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Serum amylase increased  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  1/2 (50.00%) 
Weight loss  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  1/7 (14.29%)  0/40 (0.00%)  0/2 (0.00%) 
White blood cell decreased  2/8 (25.00%)  0/2 (0.00%)  0/3 (0.00%)  2/10 (20.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Metabolism and nutrition disorders               
Acidosis  0/8 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  3/10 (30.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Anorexia  1/8 (12.50%)  1/2 (50.00%)  0/3 (0.00%)  5/10 (50.00%)  3/7 (42.86%)  11/40 (27.50%)  2/2 (100.00%) 
Dehydration  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  1/7 (14.29%)  0/40 (0.00%)  0/2 (0.00%) 
Hypercalcemia  4/8 (50.00%)  0/2 (0.00%)  1/3 (33.33%)  5/10 (50.00%)  1/7 (14.29%)  7/40 (17.50%)  1/2 (50.00%) 
Hyperglycemia  2/8 (25.00%)  0/2 (0.00%)  1/3 (33.33%)  6/10 (60.00%)  3/7 (42.86%)  9/40 (22.50%)  1/2 (50.00%) 
Hyperkalemia  0/8 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  1/10 (10.00%)  0/7 (0.00%)  2/40 (5.00%)  0/2 (0.00%) 
Hypermagnesemia  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Hypertriglyceridemia  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  0/7 (0.00%)  2/40 (5.00%)  0/2 (0.00%) 
Hyperuricemia  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Hypoalbuminemia  2/8 (25.00%)  0/2 (0.00%)  0/3 (0.00%)  3/10 (30.00%)  1/7 (14.29%)  7/40 (17.50%)  1/2 (50.00%) 
Hypocalcemia  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Hypoglycemia  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Hypokalemia  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  3/10 (30.00%)  3/7 (42.86%)  13/40 (32.50%)  1/2 (50.00%) 
Hypomagnesemia  0/8 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  1/10 (10.00%)  1/7 (14.29%)  4/40 (10.00%)  0/2 (0.00%) 
Hyponatremia  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  0/7 (0.00%)  4/40 (10.00%)  1/2 (50.00%) 
Hypophosphatemia  1/8 (12.50%)  0/2 (0.00%)  1/3 (33.33%)  3/10 (30.00%)  2/7 (28.57%)  4/40 (10.00%)  1/2 (50.00%) 
Musculoskeletal and connective tissue disorders               
Avascular necrosis  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  1/7 (14.29%)  0/40 (0.00%)  0/2 (0.00%) 
Back pain  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  3/40 (7.50%)  0/2 (0.00%) 
Bone pain  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  2/10 (20.00%)  0/7 (0.00%)  0/40 (0.00%)  1/2 (50.00%) 
Myalgia  1/8 (12.50%)  1/2 (50.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Neck pain  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Pain in extremity  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  4/40 (10.00%)  1/2 (50.00%) 
Nervous system disorders               
Depressed level of consciousness  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Dizziness  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Headache  2/8 (25.00%)  0/2 (0.00%)  0/3 (0.00%)  3/10 (30.00%)  0/7 (0.00%)  2/40 (5.00%)  1/2 (50.00%) 
Leukoencephalopathy  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Peripheral sensory neuropathy  1/8 (12.50%)  0/2 (0.00%)  1/3 (33.33%)  0/10 (0.00%)  0/7 (0.00%)  2/40 (5.00%)  0/2 (0.00%) 
Psychiatric disorders               
Anxiety  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Renal and urinary disorders               
Acute kidney injury  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Bladder spasm  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Cystitis noninfective  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Hematuria  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Reproductive system and breast disorders               
Perineal pain  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  1/7 (14.29%)  0/40 (0.00%)  0/2 (0.00%) 
Reproductive system and breast disorders - Other  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Uterine hemorrhage  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Allergic rhinitis  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Atelectasis  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  1/7 (14.29%)  0/40 (0.00%)  0/2 (0.00%) 
Bronchospasm  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Dyspnea  0/8 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  1/10 (10.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Epistaxis  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  2/10 (20.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Hypoxia  1/8 (12.50%)  0/2 (0.00%)  1/3 (33.33%)  1/10 (10.00%)  0/7 (0.00%)  2/40 (5.00%)  0/2 (0.00%) 
Pharyngeal mucositis  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  1/7 (14.29%)  0/40 (0.00%)  0/2 (0.00%) 
Pleural effusion  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Pneumonitis  0/8 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Tracheal mucositis  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  1/40 (2.50%)  0/2 (0.00%) 
Skin and subcutaneous tissue disorders               
Alopecia  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  1/7 (14.29%)  2/40 (5.00%)  0/2 (0.00%) 
Dry skin  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  0/7 (0.00%)  0/40 (0.00%)  0/2 (0.00%) 
Palmar-plantar erythrodysesthesia syndrome  1/8 (12.50%)  1/2 (50.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  2/40 (5.00%)  1/2 (50.00%) 
Pruritus  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  1/7 (14.29%)  3/40 (7.50%)  1/2 (50.00%) 
Purpura  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  1/7 (14.29%)  0/40 (0.00%)  0/2 (0.00%) 
Rash maculo-papular  2/8 (25.00%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  1/7 (14.29%)  5/40 (12.50%)  0/2 (0.00%) 
Skin and subcutaneous tissue disorders - Other  1/8 (12.50%)  0/2 (0.00%)  1/3 (33.33%)  0/10 (0.00%)  1/7 (14.29%)  1/40 (2.50%)  0/2 (0.00%) 
Skin hyperpigmentation  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  0/7 (0.00%)  2/40 (5.00%)  0/2 (0.00%) 
Skin hypopigmentation  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  1/7 (14.29%)  0/40 (0.00%)  0/2 (0.00%) 
Skin ulceration  1/8 (12.50%)  0/2 (0.00%)  0/3 (0.00%)  0/10 (0.00%)  1/7 (14.29%)  0/40 (0.00%)  0/2 (0.00%) 
Vascular disorders               
Capillary leak syndrome  0/8 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/10 (10.00%)  0/7 (0.00%)  2/40 (5.00%)  0/2 (0.00%) 
Hypertension  1/8 (12.50%)  0/2 (0.00%)  1/3 (33.33%)  4/10 (40.00%)  0/7 (0.00%)  5/40 (12.50%)  0/2 (0.00%) 
Hypotension  2/8 (25.00%)  0/2 (0.00%)  1/3 (33.33%)  0/10 (0.00%)  1/7 (14.29%)  5/40 (12.50%)  1/2 (50.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Must obtain prior Sponsor approval.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 352-273-0567
EMail: ResultsReportingCoordinator@childrensoncologygroup.org
Layout table for additonal information
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00372619     History of Changes
Other Study ID Numbers: AAML0523
CDR0000494654 ( Other Identifier: Clinical Trials.gov )
NCI-2009-00319 ( Other Identifier: NCI Trial Identifier )
COG-AAML0523 ( Other Identifier: Children's Oncology Group )
First Submitted: September 6, 2006
First Posted: September 7, 2006
Results First Submitted: December 13, 2013
Results First Posted: February 3, 2014
Last Update Posted: June 5, 2017