Overview

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 (bilirubin transaminase (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 is mg/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