Clofarabine and Cyclophosphamide Combination in Acute Lymphoblastic Leukemia Patients
Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
Participant gender:
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.