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RECRUITING
NCT05245656
PHASE2

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

Sponsor: Kim, Seok Jin

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2022-10-18

Completion Date

2029-12-31

Last Updated

2024-08-06

Healthy Volunteers

No

Interventions

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

Locations (1)

Samsung Medical Center

Seoul, Gangnam-Gu, South Korea