Clofarabine in Chronic Lymphocytic Leukemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-02-28

Study Completion Date

2004-03-31

Brief Summary

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This is a dose-escalation study to determine the maximum tolerated dose and toxic effects of clofarabine in patients with chronic lymphocytic leukemia and other acute leukemias. Clofarabine is a synthesized hybrid nucleoside analog, which is believed to possess the better qualities of fludarabine and chlorodeoxyadenosine, the 2 most active agents against lymphoproliferative disorders. Thus, it is hoped that this drug will be more active and less toxic than similar drugs.

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Detailed Description

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The first group of patients will be treated at the starting dose level of 2 mg/m2 over 1 hour daily for 5 days. Dosage escalation will be permitted in individual patients if no toxicity occurred during the preceding course. Subsequent dose escalations will be by 50% until Grade 2 toxicity, then by 35% until the maximum tolerated dose.

Completion date provided represents the completion date of the grant per OOPD records

Conditions

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Hematologic Neoplasms Lymphoproliferative Disorders Leukemia Leukemia, Lymphocytic, Chronic

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Clofarabine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of chronic lymphocytic leukemia
* Diagnosis of other acute leukemia
* At least 2 weeks since prior chemotherapy, immunotherapy, and/or radiotherapy
* Recovered from toxic effects of prior therapy
* Bilirubin no greater than 2 mg/dL
* Creatinine no greater than 1.5 mg/dL