Phase 2
Completed N=50
Clofarabine and Cyclophosphamide Combination in Acute Lymphoblastic Leukemia Patients
Source: ClinicalTrials.gov NCT00412243 ↗Enrolled (actual)
50
Serious AEs
26.0%
Results posted
Mar 2013
Primary outcomePrimary: Maximum Tolerated Dose for Cyclophosphamide (MTD) — 200 mg/m^2
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
Phase II:
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose for Cyclophosphamide (MTD) |
200 | — |
Eligibility Criteria
Inclusion Criteria
- 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 /= 60 mL/min). Even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is /= 1 year postmenopausal or surgically sterilized).
Exclusion Criteria
- 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) /= 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
Data sourced from ClinicalTrials.gov (NCT00412243). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.