Actively Recruiting
A Study Comparing Rituximab/Bendamustin(RB) Alternating With Rituximab/Bendamustin/Cytarabin(RBAC) With RB Therapy in Elderly Patients With Mentle Cell Lymphoma
Led by Kim, Seok Jin · Updated on 2026-04-23
90
Participants Needed
1
Research Sites
375 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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, untreated, histologically confirmed CD20+ mantle cell lymphoma
- Age 60 years or older, or 60-69 years if not eligible for high-dose therapy with stem cell transplantation
- ECOG performance status of 2 or less
- Adequate heart function with LVEF 50% or higher
- Adequate kidney function with serum creatinine 2.0 mg/dL or lower or creatinine clearance 40 mL/min or higher
- Adequate liver function within specified limits of ALT and bilirubin
- Adequate blood counts with ANC 1,500/mL or higher and platelets 100,000/mL or higher (exceptions allowed for bone marrow involvement)
- Provided written informed consent
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 cancer within the past 3 years except certain localized and treated cancers
- Central nervous system involvement
- Positive for hepatitis B surface antigen or core antibody without prophylactic treatment
- History of hepatitis C infection unless negative for active infection
- Known HIV infection
- Serious unstable illnesses including congestive heart failure NYHA class 3 or higher, recent acute coronary syndrome, significant neurological or psychological disorders, severe COPD with low oxygen, recent cerebrovascular disease, non-healing wounds or fractures, or active uncontrolled infections
- Use of other experimental drugs
- Known allergies to bendamustine, rituximab, cytarabine, or mannitol
- Major surgery or significant trauma within 28 days, or open biopsy within 7 days before treatment start
- Men without vasectomy whose partners could become pregnant must agree to use effective contraception when sexually active
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
S
shin hyunjung
CONTACT
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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