At a glance
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Phase I/II Study of Clofarabine Plus Cyclophosphamide for Relapsed and Refractory Acute Lymphoblastic Leukemia (ALL)
In Brief
A Phase 2 clinical trial evaluating Clofarabine and Cyclophosphamide for Burkitt's Lymphoma and 2 related conditions. Completed, enrolled 51 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
40 mg/m\^2 Daily for 3 Days
Beginning dose 200 mg/m\^2 every 12 hours for 3 days