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

Recruiting now · Phase 2

Conditions studied: Mantle Cell Lymphoma

In brief

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.

Key facts

Study ID: NCT05245656
Run by: Kim, Seok Jin
People needed: 90
Starts: 2022-10-18
Expected to finish: 2029-12-31
Last updated by the study team: 2026-04-23

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

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
Active uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
concomitant administration of any other experimental drugs under investigation
Known hypersensitivity to bendamustine, rituximab, cytarabine, or mannitol
major surgical procedure or significant trauma within 28 days before start of study treatment, open biopsy within 7 days before start of study treatment
If the patient's partner is a woman who could possibly get pregnant, men who didn't have a vasectomy must agree to use medically recommended methods for adequate contraception (tubal ligation, intrauterine devices, or barriers [diaphragm, cervical cap] in the patient's partner and the use of condoms in men) when sexually active.

Where it is running

Samsung Medical Center — Seoul, Gangnam-Gu, South Korea (enrolling)

Full record on ClinicalTrials.gov

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