Clinical Trials Directory

Trials / Terminated

TerminatedNCT02614508

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

A Phase I Study of Buparlisib (BKM120) and Ofatumumab or Ibrutinib in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
1 (actual)
Sponsor
Emory University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DRUGBuparlisibGiven PO
DRUGIbrutinibGiven PO
BIOLOGICALOfatumumabGiven IV

Timeline

Start date
2016-01-01
Primary completion
2019-08-01
Completion
2019-08-01
First posted
2015-11-25
Last updated
2019-09-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02614508. Inclusion in this directory is not an endorsement.