NCT05245656 A Study Comparing Rituximab/Bendamustin(RB) Alternating With Rituximab/Bendamustin/Cytarabin(RBAC) With RB Therapy in Elderly Patients With Mentle Cell Lymphoma
| NCT ID | NCT05245656 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Kim, Seok Jin |
| Condition | Mantle Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2022-10-18 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2022-10-18 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. newly diagnosed, previously untreated, histologically confirmed CD20+ mantle cell lymphoma, confirmed by WHO classification criteria 2. age ≥70 years or 60-69 years if the patients are ineligible for high-dose therapy with autologous stem cell transplantation. 3. ECOG performance status 2 or less 4. 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) 5. Written informed consent Exclusion Criteria: 1. In-situ mantle cell lymphoma 2. Ann Arbor stage 1 disease 3. Prior treatment for Hodgkin lymphoma or non-Hodgkin lymphoma within the last 5 years. 4. 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, 5. Central nervous system involvement 6. HBsAg (+) or anti-HBc Ab (+) (patients will be eligible if they receive appropriate prophylactic antiviral therapy using entecavir, tenofovir, and so on) 7. History of prior hepatitis C infection (patients positive for HCV IgG will be eligible if they are negative for HCV-RNA) 8. Known history of human immunodeficiency virus (HIV) infection 9. 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 10. concomitant administration of any other experimental drugs under investigation 11. Known hypersensitivity to bendamustine, rituximab, cytarabine, or mannitol 12. major surgical procedure or significant trauma within 28 days before start of study treatment, open biopsy within 7 days before start of study treatment 13. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05245656 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Mantle Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05245656 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05245656 currently recruiting?
Yes, NCT05245656 is actively recruiting participants. Contact the research team at hjds.shin@samsung.com for enrollment information.
Where is the NCT05245656 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05245656 clinical trial?
NCT05245656 is sponsored by Kim, Seok Jin. The trial plans to enroll 90 participants.