Obinutuzumab, Ibrutinib, and Venetoclax for the Treatment of Previously Untreated Stage II-IV Follicular Lymphoma

Part of paid clinical trials in Fresno, California.

Sponsor
University of California, Davis
Study ID
NCT04450173
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Ann Arbor Stage II Follicular Lymphoma
  • Ann Arbor Stage III Follicular Lymphoma
  • Ann Arbor Stage IV Follicular Lymphoma
  • Grade 1 Follicular Lymphoma
  • Grade 2 Follicular Lymphoma
  • Grade 3a Follicular Lymphoma

Eligibility Criteria

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

Interventions

Study Details

This phase II trial studies how well obinutuzumab, ibrutinib, and venetoclax work in treating patients with previously untreated stage II-IV follicular lymphoma. Immunotherapy with obinutuzumab may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Ibrutinib and venetoclax may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving obinutuzumab, ibrutinib, and venetoclax together may work better in treating follicular lymphoma compared to each drug alone.

Key Dates

Start date
Feb 24, 2021
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (obinutuzumab, venetoclax, ibrutinib)
    Patients receive obinutuzumab IV over 60 minutes on days 1, 8, and 15 of cycle 1, day 1 of cycles 2-6, 8, 10, 12, 14, 16, 18, 20, 22, and 24. Patients also receive venetoclax PO QD on days 1-28 (days 4-28 of cycle 1) and ibrutinib PO QD on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Complete response (CR) rate [ Time Frame: At 12 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of California, San Francisco (UCSF) FresnoFresnoCalifornia93701-
University of California, Los AngelesLos AngelesCalifornia90095-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
University of California, San DiegoSan DiegoCalifornia92037-

Find similar trials in Fresno, CA

By research site
University of California, San Francisco (UCSF) Fresno· Fresno, CAUniversity of California, Los Angeles· Los Angeles, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CAUniversity of California, San Diego· San Diego, CA

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