Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Phase 1b/2a Study of ABT-888 in Combination With Bendamustine +/- Rituximab in Lymphoma, Multiple Myeloma and Solid Tumors
This phase I/II trial studies the side effects and the best dose of veliparib when given together with bendamustine hydrochloride and rituximab and to see how well they work in treating patients with lymphoma, multiple myeloma, or solid tumors that have come back or have not responded to treatment. Veliparib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as bendamustine hydrochloride, 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 find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Giving veliparib together with bendamustine hydrochloride and rituximab may kill more cancer cells.
PRIMARY OBJECTIVES:
I. To determine the maximum-tolerated dose (MTD) of ABT-888 (veliparib) in combination with
bendamustine (bendamustine hydrochloride) in patients with solid tumors, lymphoma, or
multiple myeloma. (Phase Ib) II. To establish the safety of ABT-888 in combination with
bendamustine and rituximab in an expansion cohort of patients with non-Hodgkin lymphoma
(NHL). (Phase Ib) III. To assess the toxicity profile of this regimen in the above patients.
(Phase Ib) IV. To determine the complete response (CR) rate in patients with indolent NHL or
mantle cell lymphoma (MCL) treated with ABT-888 + bendamustine + rituximab. (Phase IIa)
SECONDARY OBJECTIVES:
I. To assess response rates and survival parameters of patients treated with ABT-888 +
bendamustine +/- rituximab. (Phase Ib) II. To assess pharmacokinetic parameters of ABT-888 in
this regimen. (Phase Ib) III. To assess progression-free survival, overall survival, and
duration of remission of patients with indolent NHL and MCL treated with ABT-888 +
bendamustine + rituximab. (Phase IIa)
OUTLINE: This is a phase I, dose-escalation study of veliparib followed by a phase II study.
Patients receive veliparib orally (PO) twice daily (BID) on days 1-7 and bendamustine
hydrochloride intravenously (IV) over 30-60 minutes on days 1-2. Treatment repeats every 28
days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Once the maximum-tolerated dose is determined, a cohort of patients receives veliparib and
bendamustine hydrochloride as above and rituximab IV on day 1. Treatment repeats every 28
days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
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