Leukemia Clinical Trial
Official title:
A Phase 1 Study of Obatoclax Mesylate (GX15-070MS) in Combination With Fludarabine-Based Chemoimmunotherapy in Previously Treated Patients With B-Cell Chronic Lymphocytic Leukemia (B-CLL)
Obatoclax may stop the growth of chronic lymphocytic leukemia by blocking blood flow to the cancer and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving obatoclax together with fludarabine and rituximab may kill more cancer cells. This phase I trial is studying the side effects and best dose of obatoclax when given together with fludarabine and rituximab in treating patients with B-cell chronic lymphocytic leukemia.
PRIMARY OBJECTIVE:
I. To determine the maximum tolerated dose of obatoclax mesylate in combination with
fludarabine phosphate-rituximab (FR) in patients with relapsed chronic lymphocytic leukemia.
SECONDARY OBJECTIVES:
I. To evaluate toxicity of obatoclax mesylate in combination with FR in this patient
population.
II. To determine objective response rate and progression-free survival of obatoclax mesylate
in combination with FR.
III. To correlate levels of anti-apoptotic Bcl-2 family members with drug response.
IV. To determine whether apoptosis is induced via the mitochondrial pathway in response to
obatoclax mesylate and further enhanced by FR.
OUTLINE: This is a dose-escalation study of obatoclax mesylate.
Patients receive obatoclax mesylate IV over 3 hours on days 1 and 3, fludarabine IV over
20-30 minutes on days 1-5, and rituximab IV over 4 hours on day 1 (days 1 and 3 of course 1
only). Treatment repeats every 28 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
Patients undergo peripheral blood collection for correlative studies. Samples are analyzed
for expression of pro- and anti-apoptotic Bcl-2 family members by western blot; apoptosis
induction by measurement of lymphocyte count, Annexin V staining, and Caspase and PARP
cleavage; activated Bax by immunoprecipitation; and Bax promoter polymorphism by PCR
amplification and direct sequencing.
After completion of study therapy, patients are followed every 6 months.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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