RecruitingPhase 2NCT05245656

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


Sponsor

Kim, Seok Jin

Enrollment

90 participants

Start Date

Oct 18, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two chemotherapy approaches for older patients with a blood cancer called mantle cell lymphoma. One group receives a standard two-drug regimen (rituximab and bendamustine), while the other alternates between that regimen and a three-drug combination that includes cytarabine. The goal is to find which approach works better for patients who are not able to tolerate intensive stem cell transplants. **You may be eligible if...** - You have been newly diagnosed with mantle cell lymphoma and have not been treated before - You are 70 or older, or between 60-69 and not a candidate for high-dose therapy with stem cell transplant - You are in reasonably good physical condition - Your heart, kidneys, liver, and blood counts are at adequate levels **You may NOT be eligible if...** - You have very early stage (Stage 1) disease or non-invasive (in-situ) mantle cell lymphoma - You have had prior treatment for lymphoma in the last 5 years - You have another active cancer (with some exceptions) - You have cancer in your brain or spinal fluid - You have active hepatitis B, hepatitis C, or HIV - You have serious heart, lung, neurological, or infectious conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGRB/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

DRUGRB

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05245656


Related Trials