Obinutuzumab, Venetoclax, and Lenalidomide in Treating Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Beth Christian
Study ID
NCT02992522
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • B-Cell
  • B-Cell Lymphoma, Unspecified
  • Grade 1 Follicular Lymphoma
  • Grade 2 Follicular Lymphoma
  • Grade 3a Follicular Lymphoma
  • Recurrent Burkitt Lymphoma
  • Recurrent Diffuse Large B-Cell Lymphoma
  • Recurrent Follicular Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Refractory Burkitt Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma
  • Refractory Follicular Lymphoma
  • Transformed Recurrent Non-Hodgkin Lymphoma

Eligibility Criteria

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

Interventions

  • Lenalidomide — DRUG
    Given PO
  • Obinutuzumab — BIOLOGICAL
    Given IV
  • Venetoclax — DRUG
    Given PO

Study Details

This phase I study studies the side effects and best dose of venetoclax and lenalidomide when given together with obinutuzumab in treating patients with B-cell non-Hodgkin lymphoma that has returned after a period of improvement or not responding to treatment. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving obinutuzumab, venetoclax, and lenalidomide may work better in treating patients with B-cell non-Hodgkin lymphoma.

Key Dates

Start date
Feb 21, 2017
Status verified
Sep 2025
Primary completion
Aug 15, 2026
Completion
Aug 15, 2026

Study Design

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

Arms

  • Experimental: Treatment (lenalidomide, venetoclax, obinutuzumab)
    Patients receive lenalidomide PO on days 1-21 and venetoclax PO on days 1-28. Patients also receive obinutuzumab IV on days 1, 8, and 15 of course 1, and day 1 of courses 2-6. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

MTD defined as the highest level at which no more than 6 patients experience a DLT assessed by National Cancer Institute Common Terminology Criteria of Adverse Events version 4 [ Time Frame: Up to 28 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
Emory UniversityAtlantaGeorgia30322-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

Find similar trials in Atlanta, GA

By research site
Emory University· Atlanta, GAOhio State University Comprehensive Cancer Center· Columbus, OH

Related Studies