ClinicalTrials.gov
ClinicalTrials.gov Menu

3-AP and Fludarabine in Treating Patients With Myeloproliferative Disorders, Chronic Myelomonocytic Leukemia, or Accelerated Phase or Blastic Phase Chronic Myelogenous 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: NCT00381550
Recruitment Status : Completed
First Posted : September 28, 2006
Results First Posted : May 21, 2014
Last Update Posted : January 6, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Accelerated Phase Chronic Myelogenous Leukemia
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
Blastic Phase Chronic Myelogenous Leukemia
Chronic Eosinophilic Leukemia
Chronic Myelomonocytic Leukemia
Essential Thrombocythemia
Philadelphia Chromosome Negative Chronic Myelogenous Leukemia
Polycythemia Vera
Primary Myelofibrosis
Relapsing Chronic Myelogenous Leukemia
Interventions Drug: fludarabine phosphate
Drug: triapine
Procedure: laboratory biomarker analysis
Enrollment 35
Recruitment Details Patient's presenting for treatment of a myeloproliferative disease were considered for participation.
Pre-assignment Details Once patient consented to treatment, treatment began shortly there after.
Arm/Group Title Triapine and Fludarabine Phosphate
Hide Arm/Group Description Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 35
Completed 35
Not Completed 0
Arm/Group Title Arm I
Hide Arm/Group Description Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
  48.6%
>=65 years
18
  51.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants
65  (40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
18
  51.4%
Male
17
  48.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants
35
1.Primary Outcome
Title Response Rate Including Complete Response, Partial Response, and Hematological Improvement Assessed by Blood Cell Counts, Number of Blasts in Bone Marrow, and Clinical Evaluation
Hide Description Bone marrow aspiration and biopsies were performed prior to treatment, during week 3 of the first cycle, at the time of hematologic recovery from all cycles of therapy (defined as neutrophil count >500/mm3 and platelets >20,000/mm3 independently of transfusion), or at any time that leukemia regrowth was suspected. The overall response rate was defined as complete remission, partial remission, or hematologic improvement, lasting for ≥30 days. Given the different subsets of diseases, standardized response criteria were used for CMML (the Myelodysplastic Syndrome International Working Group criteria),33 CMML transforming to acute myeloid leukemia (standard AML response criteria) , accelerated MPN (Giles et al.), and transformation of MPN to secondary AML (Mascarenhas et al.).
Time Frame Up to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:
Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
18
2.Primary Outcome
Title Incidence of Grade 3 or 4 Drug-related Non-hematologic Toxicity as Assessed by NCI CTCAE v3.0
Hide Description [Not Specified]
Time Frame Up to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:
Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
35
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I
Hide Arm/Group Description Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Arm I
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I
Affected / at Risk (%) # Events
Total   18/35 (51.43%)    
Infections and infestations   
Infections   7/35 (20.00%)  7
Investigations   
Kidney injury   6/35 (17.14%)  6
Metabolism and nutrition disorders   
Hyperbilirubinemia   2/35 (5.71%)  2
Tumor Lysis syndrome   3/35 (8.57%)  3
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I
Affected / at Risk (%) # Events
Total   35/35 (100.00%)    
General disorders   
Allergic reaction   5/35 (14.29%)  5
Anaphylaxis   2/35 (5.71%)  2
Fever   11/35 (31.43%)  11
Metabolism and nutrition disorders   
Acidosis   10/35 (28.57%)  10
Elevated bilirubin   14/35 (40.00%)  14
Elevated creatinine   8/35 (22.86%)  8
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Name/Title: Michael McDevitt, MD PhD
Organization: Sidney Kimmel Comprehensive Cancer Center
Phone: 410-955-9175
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00381550     History of Changes
Other Study ID Numbers: NCI-2009-00209
NCI-2009-00209 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
J0638 ( Other Identifier: Johns Hopkins University/Sidney Kimmel Cancer Center )
7704 ( Other Identifier: CTEP )
P30CA006973 ( U.S. NIH Grant/Contract )
U01CA070095 ( U.S. NIH Grant/Contract )
First Submitted: September 26, 2006
First Posted: September 28, 2006
Results First Submitted: April 23, 2014
Results First Posted: May 21, 2014
Last Update Posted: January 6, 2015