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New drug combo aims to improve outcomes for elderly lymphoma patients

NCT ID NCT05245656

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

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

60 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Samsung Medical Center

    RECRUITING

    Seoul, Gangnam-Gu, 06351, South Korea

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