NCT03295240

The Study of Bendamustine, Rituximab, Ibrutinib, and Venetoclax in Relapsed, Refractory Mantle Cell Lymphoma

Phase I Study of Bendamustine, Rituximab, Ibrutinib, and Venetoclax in Relapsed, Refractory Mantle Cell Lymphoma

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the safety of Venetoclax in combination with FDA approved treatments Bendamustine, Rituximab and Ibrutinib (BR-I). This study will examine the effects Venetoclax has on participants when it is given in combination with BR-I.

Conditions

• Mantle Cell Lymphoma
• Lymphoma

Interventions

Type	Name	Description
DRUG	BR-I (bendamustine, rituximab, ibrutinib)	The BR-I (bendamustine, rituximab, ibrutinib) regimen will be administered for six 28-day cycles: bendamustine (90 mg/m2; (or 70mg/m2 for dose level -1); day 1 and 2 ), rituximab (375 mg/m2; day 1), and ibrutinib one pill or four 140mg capsules (560 mg oral daily; day 1-28).
DRUG	VEN (Venetoclax)	The initial cycle 1 VEN (Venetoclax) dose ramp-up will be: 20 mg daily for 1 week, 50 mg daily for week 2, 100 mg daily for week 3, and 200 mg daily for week 4. Thereafter, VEN will be administered at a fixed dose level of 400 mg daily for varying durations of each 28-day cycle. Now also include a -2 dose level which has the reduced 3-day duration of Ventoclax 400 mg daily.

Timeline

• Start date: 2017-09-20
• Primary completion: 2024-01-22
• Completion: 2024-01-22
• First posted: 2017-09-27
• Last updated: 2025-05-13

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study