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Trial record 83 of 115 for:    cancer | butyrate

Chemoimmunotherapy With Epratuzumab in Relapsed Acute Lymphoblastic Leukemia (ALL)

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: NCT00098839
Recruitment Status : Completed
First Posted : December 9, 2004
Results First Posted : March 26, 2015
Last Update Posted : December 12, 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: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Recurrent Childhood Acute Lymphoblastic Leukemia
Interventions Drug: L-asparaginase
Drug: doxorubicin hydrochloride
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
Biological: epratuzumab
Drug: cytarabine
Drug: prednisone
Drug: pegaspargase
Drug: dexrazoxane hydrochloride
Drug: methotrexate
Drug: etoposide
Drug: cyclophosphamide
Drug: leucovorin calcium
Biological: filgrastim
Enrollment 134
Recruitment Details  
Pre-assignment Details The phase I part of the study was completed as of August 2006. The study was amended on 11/10/2006 and Part B (phase 2 pilot) was opened on 01/08/2007 which consisted of two dosing schedules for epratuzumab: weekly for four doses during Block 1 and twice weekly for eight doses during Block 1. This report is limited to Part B (116 enrollments).
Arm/Group Title Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly
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Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, high-dose (HD) methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), Intrathecal triple therapy (ITT) (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.

L-asparaginase: Given IM

doxorubicin hydrochloride: Given IV

therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID

vincristine sulfate: Given IV

epratuzumab: Given IV

cytarabine: Given IT

prednisone: Given orally

pegaspargase: Given IM

dexrazoxane hydrochloride: Given IV

methotrexate: Given IT

etoposide: Given IV

cyclophosphamide: Given IV

leucovorin calcium: Given IV

filgrastim: Given SC

Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, high-dose (HD) methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), Intrathecal triple therapy (ITT) (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.

L-asparaginase: Given IM

doxorubicin hydrochloride: Given IV

therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID

vincristine sulfate: Given IV

epratuzumab: Given IV

cytarabine: Given IT

prednisone: Given orally

pegaspargase: Given IM

dexrazoxane hydrochloride: Given IV

methotrexate: Given IT

etoposide: Given IV

cyclophosphamide: Given IV

leucovorin calcium: Given IV

filgrastim: Given SC

Period Title: Overall Study
Started 56 60
Completed 24 27
Not Completed 32 33
Reason Not Completed
Adverse Event             5             2
Death             1             2
Physician Decision             4             14
Withdrawal by Subject             1             0
Refusal of further protocol therapy             3             1
Relapse             6             3
M2/M3 marrow on Day 15 of Block 2             10             11
Ineligible             2             0
Arm/Group Title Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly Total
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Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.

L-asparaginase: Given IM

doxorubicin hydrochloride: Given IV

therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID

vincristine sulfate: Given IV

epratuzumab: Given IV

cytarabine: Given IT

prednisone: Given orally

pegaspargase: Given IM

dexrazoxane hydrochloride: Given IV

methotrexate: Given IT

etoposide: Given IV

cyclophosphamide: Given IV

leucovorin calcium: Given IV

filgrastim: Given SC

Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.

L-asparaginase: Given IM

doxorubicin hydrochloride: Given IV

therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID

vincristine sulfate: Given IV

epratuzumab: Given IV

cytarabine: Given IT

prednisone: Given orally

pegaspargase: Given IM

dexrazoxane hydrochloride: Given IV

methotrexate: Given IT

etoposide: Given IV

cyclophosphamide: Given IV

leucovorin calcium: Given IV

filgrastim: Given SC

Total of all reporting groups
Overall Number of Baseline Participants 54 60 114
Hide Baseline Analysis Population Description
Ineligible patients (2) are not included in baseline population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants 60 participants 114 participants
10.5  (5.54) 9.7  (5.44) 10.1  (5.48)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 60 participants 114 participants
<=18 years
48
  88.9%
55
  91.7%
103
  90.4%
Between 18 and 65 years
6
  11.1%
5
   8.3%
11
   9.6%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 60 participants 114 participants
Female
23
  42.6%
29
  48.3%
52
  45.6%
Male
31
  57.4%
31
  51.7%
62
  54.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 60 participants 114 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
3
   5.0%
3
   2.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
  18.5%
6
  10.0%
16
  14.0%
White
38
  70.4%
46
  76.7%
84
  73.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
6
  11.1%
5
   8.3%
11
   9.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 60 participants 114 participants
Hispanic or Latino
14
  25.9%
20
  33.3%
34
  29.8%
Not Hispanic or Latino
37
  68.5%
38
  63.3%
75
  65.8%
Unknown or Not Reported
3
   5.6%
2
   3.3%
5
   4.4%
1.Primary Outcome
Title Remission Re-induction (CR2) Rate
Hide Description The proportion of patients who achieved complete response at the end Block 1 of re-induction therapy. Complete Remission (CR) - Attainment of M1 bone marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (ANC >1000/uL and platelet count >100,000/uL). Partial Remission (PR) - Complete disappearance of circulating blasts and achievement of M2 marrow status (5% or < 25% blast cells and adequate cellularity). Partial Remission Cytolytic (PRCL) - Complete disappearance of circulating blasts and achievement of at least 50% reduction from baseline in bone marrow blast count. Minimal Response Cytolytic (MRCL) - 50% reduction in the peripheral blast count with no increase in peripheral white blood cell count.
Time Frame At the end of Block 1 of re-induction therapy (day 36)
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Hide Analysis Population Description
Evaluable patients at the end of Block 1. There were 2 ineligible patients for once weekly arm and 6 patients not evaluable at the end of block 1 re-induction therapy. There were 10 patients for twice weekly arm not evaluable at the end of block 1 re-induction therapy.
Arm/Group Title Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly
Hide Arm/Group Description:

Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.

L-asparaginase: Given IM

doxorubicin hydrochloride: Given IV

therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID

vincristine sulfate: Given IV

epratuzumab: Given IV

cytarabine: Given IT

prednisone: Given orally

pegaspargase: Given IM

dexrazoxane hydrochloride: Given IV

methotrexate: Given IT

etoposide: Given IV

cyclophosphamide: Given IV

leucovorin calcium: Given IV

filgrastim: Given SC

Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.

L-asparaginase: Given IM

doxorubicin hydrochloride: Given IV

therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID

vincristine sulfate: Given IV

epratuzumab: Given IV

cytarabine: Given IT

prednisone: Given orally

pegaspargase: Given IM

dexrazoxane hydrochloride: Given IV

methotrexate: Given IT

etoposide: Given IV

cyclophosphamide: Given IV

leucovorin calcium: Given IV

filgrastim: Given SC

Overall Number of Participants Analyzed 48 50
Measure Type: Number
Unit of Measure: proportion of participants
.646 .660
2.Primary Outcome
Title Event-free Survival Rate
Hide Description Proportion of patients who were event free at 4 months
Time Frame At 4 months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable patients at the end of Block 1. There were 2 ineligible patients for once weekly arm and 6 patients not evaluable at the end of block 1 re-induction therapy. There were 10 patients for twice weekly arm not evaluable at the end of block 1 re-induction therapy.
Arm/Group Title Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly
Hide Arm/Group Description:

Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.

L-asparaginase: Given IM

doxorubicin hydrochloride: Given IV

therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID

vincristine sulfate: Given IV

epratuzumab: Given IV

cytarabine: Given IT

prednisone: Given orally

pegaspargase: Given IM

dexrazoxane hydrochloride: Given IV

methotrexate: Given IT

etoposide: Given IV

cyclophosphamide: Given IV

leucovorin calcium: Given IV

filgrastim: Given SC

Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.

L-asparaginase: Given IM

doxorubicin hydrochloride: Given IV

therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID

vincristine sulfate: Given IV

epratuzumab: Given IV

cytarabine: Given IT

prednisone: Given orally

pegaspargase: Given IM

dexrazoxane hydrochloride: Given IV

methotrexate: Given IT

etoposide: Given IV

cyclophosphamide: Given IV

leucovorin calcium: Given IV

filgrastim: Given SC

Overall Number of Participants Analyzed 48 50
Measure Type: Number
Unit of Measure: Proportion of participants
.604 .640
3.Primary Outcome
Title Rate of Minimal Residual Disease (MRD) < 0.01%
Hide Description Proportion of patients (evaluable and had MRD measured at the end of Block 1) who had MRD < 0.01%.
Time Frame At the end of Block 1 of re-induction therapy (day 36)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable patients who had MRD measured at the end of Block 1. There were 2 ineligible patients for once weekly arm and 13 patients where MRD was not measured at the end of block 1 re-induction therapy. There were 16 patients for twice weekly arm where MRD was not measured at the end of block 1 re-induction therapy.
Arm/Group Title Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly
Hide Arm/Group Description:

Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.

L-asparaginase: Given IM

doxorubicin hydrochloride: Given IV

therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID

vincristine sulfate: Given IV

epratuzumab: Given IV

cytarabine: Given IT

prednisone: Given orally

pegaspargase: Given IM

dexrazoxane hydrochloride: Given IV

methotrexate: Given IT

etoposide: Given IV

cyclophosphamide: Given IV

leucovorin calcium: Given IV

filgrastim: Given SC

Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.

L-asparaginase: Given IM

doxorubicin hydrochloride: Given IV

therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID

vincristine sulfate: Given IV

epratuzumab: Given IV

cytarabine: Given IT

prednisone: Given orally

pegaspargase: Given IM

dexrazoxane hydrochloride: Given IV

methotrexate: Given IT

etoposide: Given IV

cyclophosphamide: Given IV

leucovorin calcium: Given IV

filgrastim: Given SC

Overall Number of Participants Analyzed 41 44
Measure Type: Number
Unit of Measure: Proportion of participants
.195 .295
4.Secondary Outcome
Title Pharmacokinetics
Hide Description Mean trough serum concentration measured before final dose of epratuzumab.
Time Frame Up to day 36
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics (PK) were added to the protocol with amendment 5A for the twice weekly dosing schedule of Epratuzumab. Hence, PK studies were limited to evaluable patients on this Arm only.
Arm/Group Title Twice Weekly Dosing Schedule
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Epratuzumab 360 mg/m2 x 8 doses – Part B (Amendment 5)
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: ug/mL
501  (149)
Time Frame [Not Specified]
Adverse Event Reporting Description SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients (2) are not included in adverse event reporting for the once weekly arm.
 
Arm/Group Title Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly
Hide Arm/Group Description

Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.

L-asparaginase: Given IM

doxorubicin hydrochloride: Given IV

therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID

vincristine sulfate: Given IV

epratuzumab: Given IV

cytarabine: Given IT

prednisone: Given orally

pegaspargase: Given IM

dexrazoxane hydrochloride: Given IV

methotrexate: Given IT

etoposide: Given IV

cyclophosphamide: Given IV

leucovorin calcium: Given IV

filgrastim: Given SC

Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.

L-asparaginase: Given IM

doxorubicin hydrochloride: Given IV

therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID

vincristine sulfate: Given IV

epratuzumab: Given IV

cytarabine: Given IT

prednisone: Given orally

pegaspargase: Given IM

dexrazoxane hydrochloride: Given IV

methotrexate: Given IT

etoposide: Given IV

cyclophosphamide: Given IV

leucovorin calcium: Given IV

filgrastim: Given SC

All-Cause Mortality
Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/54 (29.63%)      20/60 (33.33%)    
Blood and lymphatic system disorders     
Anemia  4/54 (7.41%)  4 2/60 (3.33%)  2
Disseminated intravascular coagulation  1/54 (1.85%)  1 2/60 (3.33%)  2
Febrile neutropenia  5/54 (9.26%)  5 11/60 (18.33%)  11
Cardiac disorders     
Cardiac arrest  1/54 (1.85%)  1 0/60 (0.00%)  0
Cardiac disorders - Other  1/54 (1.85%)  1 0/60 (0.00%)  0
Conduction disorder  0/54 (0.00%)  0 1/60 (1.67%)  1
Sinus bradycardia  0/54 (0.00%)  0 3/60 (5.00%)  3
Sinus tachycardia  1/54 (1.85%)  1 2/60 (3.33%)  2
Ventricular arrhythmia  0/54 (0.00%)  0 1/60 (1.67%)  1
Gastrointestinal disorders     
Abdominal pain  2/54 (3.70%)  2 4/60 (6.67%)  4
Colitis  0/54 (0.00%)  0 1/60 (1.67%)  1
Colonic fistula  0/54 (0.00%)  0 1/60 (1.67%)  1
Colonic perforation  1/54 (1.85%)  1 1/60 (1.67%)  1
Constipation  0/54 (0.00%)  0 1/60 (1.67%)  1
Diarrhea  0/54 (0.00%)  0 1/60 (1.67%)  1
Enterocolitis  0/54 (0.00%)  0 1/60 (1.67%)  1
Gastroparesis  0/54 (0.00%)  0 1/60 (1.67%)  1
Mucositis oral  0/54 (0.00%)  0 1/60 (1.67%)  1
Nausea  0/54 (0.00%)  0 1/60 (1.67%)  1
Oral pain  0/54 (0.00%)  0 1/60 (1.67%)  1
Pancreatitis  2/54 (3.70%)  2 2/60 (3.33%)  2
Vomiting  0/54 (0.00%)  0 1/60 (1.67%)  1
General disorders     
Chills  0/54 (0.00%)  0 1/60 (1.67%)  1
Death NOS  0/54 (0.00%)  0 2/60 (3.33%)  2
Edema limbs  2/54 (3.70%)  2 1/60 (1.67%)  1
Pain  0/54 (0.00%)  0 1/60 (1.67%)  1
Hepatobiliary disorders     
Hepatic failure  1/54 (1.85%)  1 2/60 (3.33%)  2
Immune system disorders     
Anaphylaxis  1/54 (1.85%)  1 1/60 (1.67%)  1
Infections and infestations     
Catheter related infection  1/54 (1.85%)  1 2/60 (3.33%)  2
Enterocolitis infectious  1/54 (1.85%)  1 1/60 (1.67%)  1
Eye infection  1/54 (1.85%)  1 0/60 (0.00%)  0
Infections and infestations - Other  16/54 (29.63%)  21 20/60 (33.33%)  21
Sepsis  0/54 (0.00%)  0 2/60 (3.33%)  2
Skin infection  1/54 (1.85%)  1 0/60 (0.00%)  0
Upper respiratory infection  0/54 (0.00%)  0 1/60 (1.67%)  1
Injury, poisoning and procedural complications     
Vascular access complication  1/54 (1.85%)  1 1/60 (1.67%)  1
Investigations     
Activated partial thromboplastin time prolonged  1/54 (1.85%)  1 1/60 (1.67%)  1
Alanine aminotransferase increased  3/54 (5.56%)  3 5/60 (8.33%)  5
Aspartate aminotransferase increased  4/54 (7.41%)  4 4/60 (6.67%)  4
Blood bilirubin increased  3/54 (5.56%)  3 1/60 (1.67%)  1
Creatinine increased  1/54 (1.85%)  1 0/60 (0.00%)  0
Electrocardiogram QT corrected interval prolonged  0/54 (0.00%)  0 1/60 (1.67%)  1
Fibrinogen decreased  4/54 (7.41%)  4 0/60 (0.00%)  0
GGT increased  3/54 (5.56%)  3 0/60 (0.00%)  0
INR increased  2/54 (3.70%)  2 1/60 (1.67%)  1
Lipase increased  5/54 (9.26%)  5 4/60 (6.67%)  4
Lymphocyte count decreased  3/54 (5.56%)  3 0/60 (0.00%)  0
Neutrophil count decreased  5/54 (9.26%)  5 2/60 (3.33%)  2
Platelet count decreased  4/54 (7.41%)  5 2/60 (3.33%)  2
Serum amylase increased  1/54 (1.85%)  1 2/60 (3.33%)  2
White blood cell decreased  5/54 (9.26%)  5 2/60 (3.33%)  2
Metabolism and nutrition disorders     
Acidosis  0/54 (0.00%)  0 1/60 (1.67%)  1
Alkalosis  1/54 (1.85%)  1 1/60 (1.67%)  1
Anorexia  1/54 (1.85%)  1 2/60 (3.33%)  2
Dehydration  0/54 (0.00%)  0 1/60 (1.67%)  1
Glucose intolerance  1/54 (1.85%)  1 0/60 (0.00%)  0
Hyperglycemia  4/54 (7.41%)  4 2/60 (3.33%)  2
Hyperkalemia  2/54 (3.70%)  2 0/60 (0.00%)  0
Hypertriglyceridemia  0/54 (0.00%)  0 1/60 (1.67%)  1
Hypoalbuminemia  2/54 (3.70%)  2 3/60 (5.00%)  3
Hypocalcemia  4/54 (7.41%)  4 0/60 (0.00%)  0
Hypoglycemia  0/54 (0.00%)  0 1/60 (1.67%)  1
Hypokalemia  3/54 (5.56%)  3 4/60 (6.67%)  4
Hyponatremia  4/54 (7.41%)  4 1/60 (1.67%)  1
Hypophosphatemia  2/54 (3.70%)  2 0/60 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Abdominal soft tissue necrosis  0/54 (0.00%)  0 1/60 (1.67%)  1
Arthralgia  1/54 (1.85%)  1 0/60 (0.00%)  0
Pain in extremity  1/54 (1.85%)  1 1/60 (1.67%)  1
Nervous system disorders     
Cognitive disturbance  0/54 (0.00%)  0 1/60 (1.67%)  1
Dizziness  0/54 (0.00%)  0 1/60 (1.67%)  1
Dysphasia  0/54 (0.00%)  0 1/60 (1.67%)  1
Encephalopathy  0/54 (0.00%)  0 2/60 (3.33%)  2
Headache  0/54 (0.00%)  0 1/60 (1.67%)  1
Intracranial hemorrhage  0/54 (0.00%)  0 1/60 (1.67%)  1
Nervous system disorders - Other  0/54 (0.00%)  0 2/60 (3.33%)  2
Peripheral motor neuropathy  1/54 (1.85%)  1 0/60 (0.00%)  0
Seizure  0/54 (0.00%)  0 1/60 (1.67%)  1
Anxiety  1/54 (1.85%)  1 0/60 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  2/54 (3.70%)  2 1/60 (1.67%)  1
Hematuria  1/54 (1.85%)  1 0/60 (0.00%)  0
Proteinuria  1/54 (1.85%)  1 0/60 (0.00%)  0
Renal and urinary disorders - Other  1/54 (1.85%)  1 1/60 (1.67%)  1
Urinary frequency  1/54 (1.85%)  1 0/60 (0.00%)  0
Urinary tract pain  0/54 (0.00%)  0 1/60 (1.67%)  1
Respiratory, thoracic and mediastinal disorders     
Apnea  0/54 (0.00%)  0 2/60 (3.33%)  2
Epistaxis  0/54 (0.00%)  0 1/60 (1.67%)  1
Hypoxia  4/54 (7.41%)  4 1/60 (1.67%)  1
Pleural effusion  1/54 (1.85%)  1 0/60 (0.00%)  0
Pneumonitis  2/54 (3.70%)  2 0/60 (0.00%)  0
Skin and subcutaneous tissue disorders     
Purpura  0/54 (0.00%)  0 1/60 (1.67%)  1
Skin and subcutaneous tissue disorders - Other  0/54 (0.00%)  0 1/60 (1.67%)  1
Skin ulceration  0/54 (0.00%)  0 1/60 (1.67%)  1
Vascular disorders     
Capillary leak syndrome  1/54 (1.85%)  1 0/60 (0.00%)  0
Hypertension  2/54 (3.70%)  2 2/60 (3.33%)  2
Hypotension  4/54 (7.41%)  4 3/60 (5.00%)  3
Vascular disorders - Other  1/54 (1.85%)  1 0/60 (0.00%)  0
1
Term from vocabulary, CTCv4
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   44/54 (81.48%)      41/60 (68.33%)    
Blood and lymphatic system disorders     
Anemia  36/54 (66.67%)  45 41/60 (68.33%)  49
Febrile neutropenia  18/54 (33.33%)  18 22/60 (36.67%)  23
Cardiac disorders     
Sinus bradycardia  1/54 (1.85%)  1 0/60 (0.00%)  0
Eye disorders     
Eye disorders - Other  1/54 (1.85%)  1 1/60 (1.67%)  1
Eye pain  0/54 (0.00%)  0 1/60 (1.67%)  1
Photophobia  1/54 (1.85%)  1 1/60 (1.67%)  1
Gastrointestinal disorders     
Abdominal distension  1/54 (1.85%)  1 0/60 (0.00%)  0
Abdominal pain  3/54 (5.56%)  3 0/60 (0.00%)  0
Diarrhea  2/54 (3.70%)  2 3/60 (5.00%)  3
Ileus  1/54 (1.85%)  1 0/60 (0.00%)  0
Mucositis oral  4/54 (7.41%)  4 5/60 (8.33%)  5
Nausea  3/54 (5.56%)  3 3/60 (5.00%)  3
Oral pain  2/54 (3.70%)  2 1/60 (1.67%)  1
Pancreatitis  5/54 (9.26%)  5 2/60 (3.33%)  2
Rectal hemorrhage  1/54 (1.85%)  1 0/60 (0.00%)  0
Typhlitis  2/54 (3.70%)  2 0/60 (0.00%)  0
Vomiting  2/54 (3.70%)  2 2/60 (3.33%)  2
General disorders     
Fatigue  1/54 (1.85%)  1 1/60 (1.67%)  1
Fever  0/54 (0.00%)  0 2/60 (3.33%)  2
Irritability  1/54 (1.85%)  1 0/60 (0.00%)  0
Pain  1/54 (1.85%)  1 4/60 (6.67%)  4
Immune system disorders     
Anaphylaxis  2/54 (3.70%)  2 0/60 (0.00%)  0
Infections and infestations     
Catheter related infection  0/54 (0.00%)  0 1/60 (1.67%)  1
Enterocolitis infectious  3/54 (5.56%)  3 3/60 (5.00%)  3
Infections and infestations - Other  28/54 (51.85%)  29 19/60 (31.67%)  20
Mucosal infection  0/54 (0.00%)  0 1/60 (1.67%)  1
Penile infection  1/54 (1.85%)  1 0/60 (0.00%)  0
Sepsis  0/54 (0.00%)  0 1/60 (1.67%)  1
Skin infection  0/54 (0.00%)  0 2/60 (3.33%)  2
Small intestine infection  1/54 (1.85%)  1 0/60 (0.00%)  0
Investigations     
Activated partial thromboplastin time prolonged  1/54 (1.85%)  1 2/60 (3.33%)  2
Alanine aminotransferase increased  8/54 (14.81%)  8 15/60 (25.00%)  16
Alkaline phosphatase increased  0/54 (0.00%)  0 1/60 (1.67%)  1
Aspartate aminotransferase increased  9/54 (16.67%)  9 11/60 (18.33%)  12
Blood bilirubin increased  1/54 (1.85%)  1 2/60 (3.33%)  2
Fibrinogen decreased  2/54 (3.70%)  2 5/60 (8.33%)  5
GGT increased  3/54 (5.56%)  3 1/60 (1.67%)  1
Lipase increased  6/54 (11.11%)  6 4/60 (6.67%)  4
Lymphocyte count decreased  10/54 (18.52%)  15 22/60 (36.67%)  29
Neutrophil count decreased  38/54 (70.37%)  43 40/60 (66.67%)  42
Platelet count decreased  39/54 (72.22%)  54 38/60 (63.33%)  46
Serum amylase increased  3/54 (5.56%)  3 1/60 (1.67%)  1
Weight gain  1/54 (1.85%)  1 0/60 (0.00%)  0
Weight loss  1/54 (1.85%)  1 1/60 (1.67%)  1
White blood cell decreased  34/54 (62.96%)  44 40/60 (66.67%)  44
Metabolism and nutrition disorders     
Acidosis  3/54 (5.56%)  3 2/60 (3.33%)  3
Alkalosis  0/54 (0.00%)  0 2/60 (3.33%)  2
Anorexia  5/54 (9.26%)  5 6/60 (10.00%)  6
Dehydration  3/54 (5.56%)  3 1/60 (1.67%)  1
Glucose intolerance  0/54 (0.00%)  0 1/60 (1.67%)  1
Hypercalcemia  1/54 (1.85%)  1 0/60 (0.00%)  0
Hyperglycemia  18/54 (33.33%)  20 15/60 (25.00%)  15
Hyperkalemia  4/54 (7.41%)  4 0/60 (0.00%)  0
Hypernatremia  4/54 (7.41%)  4 0/60 (0.00%)  0
Hypertriglyceridemia  2/54 (3.70%)  2 1/60 (1.67%)  1
Hyperuricemia  2/54 (3.70%)  3 0/60 (0.00%)  0
Hypoalbuminemia  10/54 (18.52%)  10 7/60 (11.67%)  7
Hypocalcemia  9/54 (16.67%)  10 8/60 (13.33%)  8
Hypoglycemia  0/54 (0.00%)  0 1/60 (1.67%)  1
Hypokalemia  16/54 (29.63%)  16 16/60 (26.67%)  19
Hypomagnesemia  2/54 (3.70%)  2 0/60 (0.00%)  0
Hyponatremia  11/54 (20.37%)  11 9/60 (15.00%)  9
Hypophosphatemia  3/54 (5.56%)  3 5/60 (8.33%)  5
Tumor lysis syndrome  0/54 (0.00%)  0 1/60 (1.67%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1/54 (1.85%)  1 0/60 (0.00%)  0
Back pain  3/54 (5.56%)  3 4/60 (6.67%)  4
Bone pain  1/54 (1.85%)  1 0/60 (0.00%)  0
Buttock pain  1/54 (1.85%)  1 1/60 (1.67%)  1
Generalized muscle weakness  1/54 (1.85%)  1 0/60 (0.00%)  0
Neck pain  1/54 (1.85%)  1 0/60 (0.00%)  0
Pain in extremity  4/54 (7.41%)  4 2/60 (3.33%)  2
Nervous system disorders     
Arachnoiditis  1/54 (1.85%)  1 0/60 (0.00%)  0
Headache  3/54 (5.56%)  3 2/60 (3.33%)  2
Syncope  2/54 (3.70%)  2 0/60 (0.00%)  0
Renal and urinary disorders     
Proteinuria  1/54 (1.85%)  1 0/60 (0.00%)  0
Renal and urinary disorders - Other  0/54 (0.00%)  0 1/60 (1.67%)  1
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome  1/54 (1.85%)  1 0/60 (0.00%)  0
Epistaxis  1/54 (1.85%)  1 3/60 (5.00%)  3
Hypoxia  2/54 (3.70%)  2 3/60 (5.00%)  3
Pharyngolaryngeal pain  2/54 (3.70%)  2 0/60 (0.00%)  0
Pleural effusion  1/54 (1.85%)  1 0/60 (0.00%)  0
Pneumonitis  2/54 (3.70%)  2 0/60 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash maculo-papular  0/54 (0.00%)  0 1/60 (1.67%)  1
Skin and subcutaneous tissue disorders - Other  0/54 (0.00%)  0 1/60 (1.67%)  1
Vascular disorders     
Hypertension  2/54 (3.70%)  2 1/60 (1.67%)  1
Hypotension  5/54 (9.26%)  5 2/60 (3.33%)  2
Vascular disorders - Other  0/54 (0.00%)  0 1/60 (1.67%)  1
1
Term from vocabulary, CTCv4
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: 626-447-0064
EMail: resultsreportingcoordinator@childrensoncologygroup.org
Layout table for additonal information
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00098839     History of Changes
Other Study ID Numbers: ADVL04P2
NCI-2011-01624 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ADVL04P2 ( Other Identifier: Children's Oncology Group )
CDR0000396777 ( Other Identifier: Clinical Trials.gov )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: December 8, 2004
First Posted: December 9, 2004
Results First Submitted: March 3, 2015
Results First Posted: March 26, 2015
Last Update Posted: December 12, 2017