Clofarabine and Cyclophosphamide Combination in Acute Lymphoblastic Leukemia Patients
Phase I/II Study of Clofarabine Plus Cyclophosphamide for Relapsed and Refractory Acute Lymphoblastic Leukemia (ALL)
1 other identifier
interventional
51
1 country
1
Brief Summary
The goal of this clinical research study is to find the highest tolerable dose of the drugs clofarabine and cyclophosphamide that can be given together in the treatment of relapsed or refractory ALL. The safety of the combination treatment will also be studied. Objectives: Phase I:
- 1.To establish toxicities and safety of the proposed combination
- 2.To establish the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of the combination to proceed with the phase II part of the study
- 3.To establish the efficacy (complete and overall response) of the proposed combination.
- 4.To analyze pharmacokinetic (PK) and pharmacodynamic (PD) properties of clofarabine as well as the impact on DNA repair of leukemic blasts with the proposed combination.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2006
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 14, 2006
CompletedFirst Posted
Study publicly available on registry
December 18, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
March 4, 2013
CompletedMarch 12, 2013
March 1, 2013
6.1 years
December 14, 2006
January 25, 2013
March 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose for Cyclophosphamide (MTD)
MTD is dose at which there are no dose limiting toxicity (DLT) defined as any =/\> grade 3 drug-related non-hematologic toxicity that occurs within the first 14 days after start of treatment. Evaluation using continual reassessment method; 3-5 Day Cycle
First 14 days of each cycle
Study Arms (1)
Clofarabine + Cyclophosphamide
EXPERIMENTALClofarabine 40 mg/m\^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m\^2 every 12 hours for 3 days
Interventions
40 mg/m\^2 Daily for 3 Days
Beginning dose 200 mg/m\^2 every 12 hours for 3 days
Eligibility Criteria
You may qualify if:
- Previously treated ALL (including Burkitt's lymphoma and lymphoblastic lymphoma) in relapse or primary refractory. For patients in first relapse, the first remission duration may not exceed 12 months.
- Age \>/= 21 years.
- Zubrod performance status \</= 3.
- Adequate liver function (bilirubin \</= 2.5 mg/dL and Serum glutamic pyruvic transaminase (SGPT or SGOT) \</= 3 \* ULN, unless considered due to tumor), and renal function (glomerular filtration rate \[GFR\] \>/= 60 mL/min). Even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is \</= 5 mg/dL and creatinine \</= 3 mg/dL.
- Male and female patients who are fertile agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy. Female patients need a negative serum or urine pregnancy test within 14 days of study enrollment (applies only if patient is of childbearing potential. Non-childbearing is defined as \>/= 1 year postmenopausal or surgically sterilized).
You may not qualify if:
- Patients with active heart disease (New York Heart Association (NYHA) class \>/= 3 as assessed by history and physical examination).
- Patients with a cardiac ejection fraction (as measured by either Multi Gated Acquisition Scan (MUGA) or echocardiogram) \< 45% are excluded.
- Patients who receive other chemotherapy. Patients must have been off previous therapy for \>/= 2 weeks and must have recovered from acute toxicity of all previous therapy prior to enrollment. (Concurrent therapy for central nervous system (CNS) prophylaxis or treatment for CNS relapse is permitted). Treatment may start earlier if necessitated by the patient's medical condition following discussion with the Principal Investigator.
- Pregnant and breast-feeding patients are excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Genzyme, a Sanofi Companycollaborator
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stefan Fader, M.D./Associate Professor
- Organization
- The University of Texas M. D. Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Faderl, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2006
First Posted
December 18, 2006
Study Start
March 1, 2006
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
March 12, 2013
Results First Posted
March 4, 2013
Record last verified: 2013-03