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This phase I trial studies the side effects and best dose of buparlisib when given together with ofatumumab or ibrutinib in treating patients with chronic lymphocytic leukemia that has returned after a period of improvement or does not respond to treatment. Buparlisib and ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as ofatumumab, may block cancer growth in different ways by targeting certain cells. Giving buparlisib or ibrutinib and ofatumumab together may work better in treating patients with chronic lymphocytic leukemia.
I. To evaluate the safety and dose limiting toxicities (DLT) of combined ofatumumab and buparlisib in patients with previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have been exposed to ibrutinib (i.e., ibrutinib pre-treated).
II. To evaluate the safety and dose limiting toxicities (DLT) of combined ibrutinib and buparlisib in patients with previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have NOT been exposed to ibrutinib (i.e., ibrutinib naïve)
I. To determine specific toxicities associated with combined buparlisib and ofatumumab.
II. Evaluate for efficacy of buparlisib in combination with ofatumumab in ibrutinib pre-treated patients with CLL/SLL.
III. To determine specific toxicities associated with combined buparlisib and ibrutinib.
IV. To evaluate for efficacy of buparlisib in combination with ibrutinib in ibrutinib naive patients with CLL/SLL.
OUTLINE: This is a dose escalation study of buparlisib. Patients are assigned to 1 of 2 treatment cohorts.
COHORT A (ibrutinib pre-treated): Patients receive buparlisib orally (PO) once daily (QD) on days 1-28 and ofatumumab intravenously (IV) on days 1, 8, 15, and 22 during of courses 1-2; and day 1 of courses 4-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
COHORT B (ibrutinib naive): Patients receive buparlisib as in Cohort A and ibrutinib PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Recurrent Chronic Lymphocytic Leukemia
Buparlisib, Ibrutinib, Ofatumumab
Emory University/Winship Cancer Institute
Not yet recruiting
Published on BioPortfolio: 2015-11-26T23:02:29-0500
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A chronic leukemia characterized by a large number of circulating prolymphocytes. It can arise spontaneously or as a consequence of transformation of CHRONIC LYMPHOCYTIC LEUKEMIA.
A lymphoid leukemia characterized by a profound LYMPHOCYTOSIS with or without LYMPHADENOPATHY, hepatosplenomegaly, frequently rapid progression, and short survival. It was formerly called T-cell chronic lymphocytic leukemia.
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A basic helix-loop-helix transcription factor that plays a critical role in HEMATOPOIESIS and as a positive regulator in the differentiation of ERYTHROID CELLS. Chromosome translocations involving the TAL-1 gene are associated with T-CELL ACUTE LYMPHOCYTIC LEUKEMIA.
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