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Buparlisib and Ofatumumab or Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

2015-11-26 23:02:29 | BioPortfolio

Summary

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.

Description

PRIMARY OBJECTIVES:

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)

SECONDARY OBJECTIVES:

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Recurrent Chronic Lymphocytic Leukemia

Intervention

Buparlisib, Ibrutinib, Ofatumumab

Location

Emory University/Winship Cancer Institute
Atlanta
Georgia
United States
30322

Status

Not yet recruiting

Source

Emory University

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-11-26T23:02:29-0500

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Medical and Biotech [MESH] Definitions

A chronic leukemia characterized by abnormal B-lymphocytes and often generalized lymphadenopathy. In patients presenting predominately with blood and bone marrow involvement it is called chronic lymphocytic leukemia (CLL); in those predominately with enlarged lymph nodes it is called small lymphocytic lymphoma. These terms represent spectrums of the same disease.

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.

A pathologic change in leukemia in which leukemic cells permeate various organs at any stage of the disease. All types of leukemia show various degrees of infiltration, depending upon the type of leukemia. The degree of infiltration may vary from site to site. The liver and spleen are common sites of infiltration, the greatest appearing in myelocytic leukemia, but infiltration is seen also in the granulocytic and lymphocytic types. The kidney is also a common site and of the gastrointestinal system, the stomach and ileum are commonly involved. In lymphocytic leukemia the skin is often infiltrated. The central nervous system too is a common site.

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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