New drug combo aims to improve outcomes for elderly lymphoma patients
NCT ID NCT05245656
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether alternating two chemotherapy regimens (RB and RBAC) works better than the standard RB regimen alone for elderly patients newly diagnosed with mantle cell lymphoma who are not eligible for a stem cell transplant. About 90 participants will be randomly assigned to one of the two treatment groups. The study measures how long the cancer stays under control, overall survival, and side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Rituximab, Bendamustine, and Cytarabine (chemotherapy drugs)
- What this could lead to
- If this works, it could offer a more effective first-line treatment option for elderly patients with mantle cell lymphoma who cannot undergo a stem cell transplant.
- What could go wrong
- This is a phase 2 trial with only 90 participants, so results are preliminary. Adding cytarabine may increase side effects, and the benefit over standard therapy is not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2022
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Samsung Medical Center
RECRUITINGSeoul, Gangnam-Gu, 06351, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Off-the-Shelf Gene-Edited immune cells tested against Hard-to-Treat lymphoma
- Triple drug combo targets mantle cell lymphoma
- New drug joins standard chemotherapy in fight against B-Cell lymphoma
- Which lymphoma drug combo works best? a new study aims to find out
- Can a Three-Drug combo erase mantle cell lymphoma without chemotherapy?
- Can a single injection reprogram immune cells to fight cancer?