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

NCT05245656 | Recruiting Phase 2 DMC

• 1 other identifier: 2021-11-126
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression-freesurvival

  Up to 84 months

Secondary Outcomes (5)

• Overall Survival

  Up to 84 months

• Duration of Response

  Up to 84 months

• Event Free Survival

  Up to 84 months

• Overall response rate

  Up to 84 months

• Adverse events

  From the day 1 of the clinical trial to 28 days after last drug administration

Study Arms (2)

RB/RBAC alternating

EXPERIMENTAL

Every 4 weeks for 6 cycles RB (1st, 3rd, and 5th cycles) * Rituximab + Bendamustine RBAC (2nd, 4th, and 6th cycles) * Rituximab + Bendamustine + Cytarabine

Drug: RB/RBAC alternating

RB

ACTIVE COMPARATOR

Every 4 weeks for 6 cycles \- Rituximab + Bendamustine

Drug: RB

Interventions

RB/RBAC alternating DRUG

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

RB/RBAC alternating

RB DRUG

Every 4 weeks for 6 cycles * Rituximab 375mg/m2, IV, D1 * Bendamustine 90mg/m2, IV, D1-2

RB

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• newly diagnosed, previously untreated, histologically confirmed CD20+ mantle cell lymphoma, confirmed by WHO classification criteria
• age ≥70 years or 60-69 years if the patients are ineligible for high-dose therapy with autologous stem cell transplantation.
• ECOG performance status 2 or less
• Adequate organ functions
• adequate heart function: LVEF ≥50% by echocardiography or MUGA
• adequate renal function: serum creatinine ≤ 2.0mg/dL or CrCl ≥40 mL/min based on the Cockcroft-Gault method
• adequate hepatic function: ≤2.5 times the upper limit of ALT (≤5 times the upper limit of ALT if the elevation is attributed by underlying lymphoma) and ≤2 times the upper limit of ALT (≤3 times the upper limit of total bilirubin if the elevation is attributed by underlying lymphoma)
• adequate hematologic function: absolute neutrophil counts (ANC) ≥ 1,500/mL, platelet counts ≥ 100,000/mL (any ANC and platelet counts are allowed, if they were related to bone marrow involvement)
• Written informed consent

You may not qualify if:

• In-situ mantle cell lymphoma
• Ann Arbor stage 1 disease
• Prior treatment for Hodgkin lymphoma or non-Hodgkin lymphoma within the last 5 years.
• Active malignancy within the past 3 years except for localized non-melanoma skin cancer, papillary thyroid cancer, cervical carcinoma in situ, breast cancer in situ, or localized prostate cancer that has been definitely treated,
• Central nervous system involvement
• HBsAg (+) or anti-HBc Ab (+) (patients will be eligible if they receive appropriate prophylactic antiviral therapy using entecavir, tenofovir, and so on)
• History of prior hepatitis C infection (patients positive for HCV IgG will be eligible if they are negative for HCV-RNA)
• Known history of human immunodeficiency virus (HIV) infection
• any serious illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study
• Congestive heart failure ≥ NYHA class 3
• Acute coronary syndrome within 6 months (unstable angina or new-onset angina, myocardial infarct, or ventricular arrhythmia)
• History of significant neurological or psychological disorder including dementia and seizure disorder
• Severe chronic obstructive pulmonary disease with hypoxemia
• Cerebrovascular disease including transient ischemic attack within the past 6 months
• Non-healing wound, ulcer, or bone fracture

Sponsors & Collaborators

• Kim, Seok Jin: lead

Study Sites (1)

Samsung Medical Center

Seoul, Gangnam-Gu, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

kim seok jin, phD

CONTACT

82-10-9933-1766; hjds.shin@samsung.com

shin hyunjung

CONTACT

82-2-3410-6763; hjds.shin@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 18, 2022
• Study Start: October 18, 2022
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)