NCT03834688

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: PrECOG, LLC. · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Mantle cell lymphoma (MCL) is a subtype of Non-Hodgkin Lymphoma (NHL) which is considered incurable with conventional therapy. With an incidence of approximately 70,000 cases diagnosed in the United States (US) per year, the disease is rare. This is an open-label phase II study of venetoclax in combination with bendamustine and rituximab. Patients will receive induction therapy with venetoclax, bendamustine and rituximab for six cycles (1 cycle = 28 days). There will be an interim analysis after 19 patients are enrolled to evaluate for tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells which can lead to electrolyte and kidney problems. Tumor assessments will be performed after Cycle 3-4 and at end of induction therapy. Mandatory pre-treatment tumor tissue sample (i.e., obtained in the course of standard biopsy or surgery) will be required for research (if sufficient tissue is available). Mandatory bone marrow aspirate (obtained in the course of standard biopsy) and peripheral blood sample will be collected at the end of treatment for Minimal Residual Disease (MRD). MRD measures the disease remaining after treatment. Optional peripheral blood samples will also be collected for future research. 10/11/2021: Due to slower than anticipated enrollment, the study was redesigned to reflect the current historical complete response rate and with a lowered sample size for prompt primary endpoint readout.

Conditions

• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Venetoclax	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).
DRUG	Bendamustine	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.
DRUG	Rituximab	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.

Timeline

• Start date: 2020-01-13
• Primary completion: 2022-10-20
• Completion: 2024-07-26
• First posted: 2019-02-08
• Last updated: 2025-08-11
• Results posted: 2024-01-23

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study