Bendamustine, Obinutuzumab, and Venetoclax in Patients With Untreated Mantle Cell Lymphoma

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT03872180
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • CCND1 Positive
  • Mantle Cell Lymphoma
  • t(11;14) Positive

Eligibility Criteria

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

Interventions

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

Study Details

This phase II trial studies how well bendamustine, obinutuzumab, and venetoclax work in treating patients with mantle cell lymphoma. Drugs used in chemotherapy, such as bendamustine and venetoclax, 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. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving bendamustine, obinutuzumab, and venetoclax may work better in treating patients with mantle cell lymphoma.

Key Dates

Start date
Apr 11, 2019
Status verified
Jul 2025
Primary completion
Jun 6, 2022
Completion
Apr 30, 2026

Study Design

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

Arms

  • Experimental: Venetoclax, bendamustine, obinutuzumab
    Patients receive venetoclax PO on days 1-28 of course 1 and days 1-10 of subsequent courses, bendamustine IV on days 1 and 2, and obinutuzumab IV on days 1, 8, and 15 of course 1 and day 1 of subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unaccepted toxicity.

Primary Outcome Measure

Rate of Complete Response at Completion of Induction Therapy With This Combination [ Time Frame: Up to 2.5 years from study start ]

Locations (3)

FacilityCityStateZIPSite coordinators
Emory Saint Joseph's HospitalAtlantaGeorgia30342-
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-
Emory Johns Creek HospitalJohns CreekGeorgia30097-

Find similar trials in Atlanta, GA

By research site
Emory Saint Joseph's Hospital· Atlanta, GAEmory University Hospital/Winship Cancer Institute· Atlanta, GAEmory Johns Creek Hospital· Johns Creek, GA

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