Phase II Study of Bendamustine and Rituximab Plus Venetoclax in Untreated Mantle Cell Lymphoma Over 60 Years of Age

Part of paid clinical trials in Urbana, Illinois.

Sponsor
PrECOG, LLC.
Study ID
NCT03834688
Phase
PHASE2
Status
Completed

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Venetoclax — DRUG
    Cycle 1: Venetoclax by mouth daily. The dose will gradually increase during Cycle 1. (Day 1-7: 20 mg; Day 8-14: 50 mg; Day 15-21: 100 mg; Day 22-28: 200 mg.) Cycles 2-6: Venetoclax 400 mg by mouth daily on Days 1-10 (1 cycle = 28 days).
  • Bendamustine — DRUG
    Cycle 1-6: Bendamustine 90 mg/m² intravenous (IV) on Days 1 and 2 of each cycle. Bendamustine may be started at 70 mg/m² in patients over the age of 75 years with comorbid conditions or patients over the age of 80 years without comorbid conditions.
  • Rituximab — DRUG
    Cycle 1-6: Rituximab 375 mg/m² IV on Day 1 of each cycle. After 2 consecutive cycles of Rituximab IV are well tolerated, Rituximab may be given subcutaneously.

Study Details

Eligible untreated patients will receive single arm venetoclax, bendamustine and rituximab as induction therapy. After 6 cycles, maintenance rituximab may be administered per physician discretion. Venetoclax is an oral Bcl-2 family protein inhibitor. It targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with mantle cell lymphoma. Venetoclax may make the cancer cells sensitive to chemotherapy. This may help to slow down the growth of cancer or may cause cancer cells to die. The purpose of this study is to see if venetoclax in combination with bendamustine and rituximab chemotherapy is effective in treating people who have mantle cell lymphoma and to examine the side effects, good and bad, associated with this combination.

Key Dates

Start date
Jan 13, 2020
Status verified
Aug 2025
Primary completion
Oct 20, 2022
Completion
Jul 26, 2024

Study Design

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

Arms

  • Experimental: Induction
    Venetoclax, bendamustine and rituximab as induction therapy for 6 cycles of 28 days.

Primary Outcome Measure

Complete Response (CR) Rate at End of Induction [ Time Frame: Complete Response (CR) status was assessed after 6 months of induction treatment, plus an additional 2 months for end of treatment PET/CT scans. ]

Locations (7)

FacilityCityStateZIPSite coordinators
Carle Cancer CenterUrbanaIllinois61801-
Indiana University Simon Cancer CenterIndianapolisIndiana46202-
St. Joseph Mercy Hospital Cancer Care CenterAnn ArborMichigan48106-
Mayo ClinicRochesterMinnesota55905-
Washington University School of Medicine Siteman Cancer CenterSt LouisMissouri63110-
Penn State Cancer InstituteHersheyPennsylvania17033-
University of Virginia Health SystemCharlottesvilleVirginia22903-

Find similar trials in Urbana, IL

By research site
Carle Cancer Center· Urbana, ILIndiana University Simon Cancer Center· Indianapolis, INSt. Joseph Mercy Hospital Cancer Care Center· Ann Arbor, MIMayo Clinic· Rochester, MNWashington University School of Medicine Siteman Cancer Center· St Louis, MOPenn State Cancer Institute· Hershey, PA

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