Duvelisib and Nivolumab in Treating Patients With Richter Syndrome or Transformed Follicular Lymphoma

Part of paid clinical trials in Columbus, Ohio.

Sponsor
David Bond, MD
Study ID
NCT03892044
Phase
PHASE1
Status
Completed

Conditions

  • Chronic Lymphocytic Leukemia
  • Recurrent Diffuse Large B-Cell Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma
  • Richter Syndrome
  • Small Lymphocytic Lymphoma
  • Transformed Chronic Lymphocytic Leukemia to Diffuse Large B-Cell Lymphoma
  • Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
  • Transformed Small Lymphocytic Lymphoma to Diffuse Large B-Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Duvelisib — DRUG
    Given PO
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

This phase I trial studies the side effects and best dose of duvelisib when given together with nivolumab in treating patients with Richter syndrome or transformed follicular lymphoma. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving duvelisib and nivolumab may work better in treating patients with Richter syndrome or transformed follicular lymphoma compared to giving duvelisib or nivolumab alone.

Key Dates

Start date
Nov 5, 2019
Status verified
Apr 2024
Primary completion
Feb 14, 2024
Completion
Feb 14, 2024

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (duvelisib, nivolumab)
    Patients receive duvelisib PO BID on days 1-28 and nivolumab IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum-tolerated dose (MTD) of duvelisib [ Time Frame: Up to 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

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