Actively Recruiting
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
Led by Kim, Seok Jin · Updated on 2026-04-23
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of two different chemotherapy combinations as first-line treatment for elderly patients with mantle cell lymphoma who cannot undergo high-dose therapy followed by stem cell transplantation. This phase 2, multicenter, open-label randomized trial compares rituximab and bendamustine (RB) alone with a regimen alternating between rituximab/bendamustine (RB) and rituximab/bendamustine/cytarabine (RBAC). Participants are randomly assigned to one of two groups. One group receives six cycles every four weeks, alternating between RB on odd cycles (1st, 3rd, 5th) and RBAC on even cycles (2nd, 4th, 6th). The RB treatment includes rituximab and bendamustine, while RBAC adds cytarabine to the combination. The other group receives six cycles of RB alone every four weeks. Patients are stratified by age, lymphoma cell type, and risk score. During the study, participants will undergo regular assessments to monitor their response and any side effects. The main measure is progression-free survival over up to 84 months, along with overall survival, duration of response, event-free survival, response rates, and adverse events. Researchers will evaluate these outcomes to understand how well each treatment regimen works and its safety profile for this patient group.
CONDITIONS
Brief Title
A Study Comparing Rituximab/Bendamustin(RB) Alternating With Rituximab/Bendamustin/Cytarabin(RBAC) With RB Therapy in Elderly Patients With Mentle Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed, previously untreated, histologically confirmed CD20+ mantle cell lymphoma according to WHO criteria
- Age 60 years or older, including age 60-69 if ineligible for high-dose therapy with autologous stem cell transplantation
- ECOG performance status of 2 or less
- Adequate organ function including heart, kidney, liver, and blood counts
- Written informed consent provided
You will not qualify if you...
- In-situ mantle cell lymphoma
- Ann Arbor stage 1 disease
- Prior treatment for Hodgkin or non-Hodgkin lymphoma within the last 5 years
- Active malignancy within past 3 years except certain localized cancers that have been treated
- Central nervous system involvement
- Positive hepatitis B surface antigen or core antibody without appropriate antiviral therapy
- History of hepatitis C infection with detectable RNA
- Known HIV infection
- Serious unstable illnesses or medical conditions that endanger safety or study compliance
- Concurrent use of other experimental drugs
- Known allergy to bendamustine, rituximab, cytarabine, or mannitol
- Major surgery or significant trauma within 28 days before starting study treatment
- If sexually active and a male without vasectomy, agreement to use medically recommended contraception methods if partner could become pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 24 weeks (6 cycles every 4 weeks)
Participants receive assigned treatment with either six cycles of Rituximab and Bendamustine alternating with Rituximab, Bendamustine, and Cytarabine, or six cycles of Rituximab and Bendamustine only.
6 treatment cycles with visits every 4 weeks
Duration - Up to 84 months
Participants are monitored for progression-free survival, overall survival, response duration, and adverse events after treatment completion.
Periodic visits during follow-up up to 7 years
Trial Site Locations
Total: 1 location
1
Samsung Medical Center
Seoul, Gangnam-Gu, South Korea, 06351
Actively Recruiting
Research Team
K
kim seok jin, phD
S
shin hyunjung
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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