NCT05245656

A Study Comparing Rituximab/Bendamustin(RB) Alternating With Rituximab/Bendamustin/Cytarabin(RBAC) With RB Therapy in Elderly Patients With Mentle Cell Lymphoma

A Randomized Phase II Trial Comparing Rituximab/Bendamustine(RB) Alternating With Rituximab/Bendamustine/Cytarabine(RBAC) With RB as Induction Therapy in Elderly Patients With Newly Diagnosed and Transplant-ineligible Mantle Cell Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Kim, Seok Jin · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2, multicenter, open-label, active-controlled randomized trial to determine efficacy and safety of rituximab/bendamustine (RB) alternating with rituximab/bendamustine/cytarabine (RBAC) compared with standard RB alone in the first-line treatment of elderly patients with mantle cell lymphoma, who are not eligible for high-dose therapy followed by autologous stem cell transplantation.

Detailed description

Eligible patients will be randomly assigned to either the investigational treatment arm (RB alternating with RBAC) or the standard treatment arm (RB) in a 1:1 ratio. Patients will be stratified by age (≥70 years vs. 60-69), histologic morphology (blastoid/pleomorphic vs. non-blastoid/non-pleomorphic), and MIPI-C risk score (0/1 vs. 2/3).

Conditions

• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	RB/RBAC alternating	Patients assigned to the RB alternating with RBAC arm will receive six cycles of alternating RB (odd cycles) or RBAC (even cycles) RB (1st, 3rd, and 5th cycles) * Rituximab 375mg/m2, IV, D1 * Bendamustine 90mg/m2, IV, D1-2 RBAC (2nd, 4th, and 6th cycles) * Rituximab 375mg/m2, IV, D1 * Bendamustine 70mg/m2, IV, D2-3 * Cytarabine 500mg/m2, IV, D2-4
DRUG	RB	Every 4 weeks for 6 cycles * Rituximab 375mg/m2, IV, D1 * Bendamustine 90mg/m2, IV, D1-2

Timeline

• Start date: 2022-10-18
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2022-02-18
• Last updated: 2024-08-06

Locations

1 site across 1 country: South Korea