Oral Clofarabine in Chronic Lymphocytic Leukemia (CLL)

• Status: Withdrawn
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to find the highest tolerable dose of clofarabine when given to patients with CLL. The safety of this drug will also be studied.

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

Details

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

Criteria

Inclusion Criteria:

• Patients with chronic lymphocytic leukemia (CLL), CLL/PLL (as defined by FAB [French-American-British Classification]), small lymphocytic lymphoma (SLL) and prolymphocytic leukemia (PLL) who have relapsed from or are refractory to at least one fludarabine-based regimen and no greater than 2 regimens.

• Absolute neutrophil count (ANC) >= 1 x 109/L and platelet count >= 50 x 109/L.

• Adequate organ function as indicated by the following laboratory values: serum creatinine1 mg/dL, then the estimated glomerular filtration rate (GFR) must be > 60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation; serum bilirubintransaminase (AST)or alanine transaminase (ALT)
• ECOG performance status <= 2.

• Age >/= 18 years.

Exclusion Criteria:

• Patients with NYHA >/= grade 3 heart disease as assessed by history and/or physical examination.

• Pregnant or breastfeeding women or patients who are unwilling or unable to practice adequate contraception. Positive pregnancy test for women of child bearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization).

• Chemotherapy within 4 weeks of starting therapy, or concurrent anticancer therapy (chemotherapy, radiotherapy, or biologic therapy).

• Other malignancy within 3 years except in situ carcinoma.

• Unwilling or unable to provide informed consent.

• Known hypersensitivity to nucleoside analogues.

• Any other significant medical condition that compromises safety, compliance or study conduct, including but not limited to uncontrolled hypertension, unstable angina, myocardial infarction within 6 months, ventricular arrhythmia, active infection, and known hepatitis.