TGR-1202 and Ibrutinib in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT02874404
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent Diffuse Large B-Cell Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Ibrutinib — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative markers
  • PI3K-delta Inhibitor TGR-1202 — DRUG
    Given PO

Study Details

This phase IIa trial studies the side effects and how well TGR-1202 and ibrutinib work in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement or does not respond to treatment. TGR-1202 and ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Oct 7, 2016
Status verified
Sep 2023
Primary completion
Jul 1, 2019
Completion
Jul 1, 2019

Study Design

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

Arms

  • Experimental: Group A (PI3K delta inhibitor TGR-1202, ibrutinib)
    Patients receive PI3K delta inhibitor TGR-1202 PO QD on days 1-28 and ibrutinib PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
  • Experimental: Group B (Ibrutinib, PI3K delta inhibitor TGR-1202)
    Patients receive ibrutinib PO QD on days 1-28 and PI3K delta inhibitor TGR-1202 PO QD and days 9-28 of course 1 and days 1-28 of subsequent courses. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
  • Experimental: Group C (PI3K delta inhibitor TGR-1202, ibrutinib)
    Patients then receive PI3K delta inhibitor TGR-1202 PO QD and ibrutinib PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Participants With Adverse Events [ Time Frame: Up to 112 days (course 4) ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical CenterOmahaNebraska68198-

Find similar trials in Omaha, NE

By research site
University of Nebraska Medical Center· Omaha, NE

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