Clofarabine and Cyclophosphamide Combination in Acute Lymphoblastic Leukemia Patients

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Genzyme, a Sanofi Company
• Treatments: Clofarabine; Cyclophosphamide

Criteria

Inclusion Criteria:

1. 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.

2. Age >/= 21 years.

3. Zubrod performance status

4. Adequate liver function (bilirubintransaminase (SGPT or SGOT)function (glomerular filtration rate [GFR] >/= 60 mL/min). Even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin ismg/dL and creatinine

5. 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).

Exclusion Criteria:

1. Patients with active heart disease (New York Heart Association (NYHA) class >/= 3 as assessed by history and physical examination).

2. Patients with a cardiac ejection fraction (as measured by either Multi Gated Acquisition Scan (MUGA) or echocardiogram) < 45% are excluded.

3. 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.

4. Pregnant and breast-feeding patients are excluded