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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT02614508
Phase
PHASE1
Status
Terminated

Conditions

  • Recurrent Chronic Lymphocytic Leukemia
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Small Lymphocytic Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Buparlisib — DRUG
    Given PO
  • Ibrutinib — DRUG
    Given PO
  • Ofatumumab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Jan 31, 2016
Status verified
Aug 2019
Primary completion
Aug 31, 2019
Completion
Aug 31, 2019

Study Design

Enrollment
1 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A (buparlisib, ofatumumab)
    Patients receive buparlisib PO QD on days 1-28 and ofatumumab 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.
  • Experimental: Cohort B (buparlisib, ibrutinib)
    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.

Primary Outcome Measure

Maximum tolerated dose (MTD) of buparlisib when combined with ibrutinib in relapsed/refractory CLL for ibrutinib naive patients defined as the dose level at which no more than 1 of 6 patients experiences a dose-limiting toxicity [ Time Frame: 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University/Winship Cancer InstituteAtlantaGeorgia30322-

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Emory University/Winship Cancer Institute· Atlanta, GA

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