Mantle Cell LymphomaPhase 2NCT05245656
A Study Comparing Rituximab/Bendamustin(RB) Alternating With Rituximab/Bendamustin/Cytarabin(RBAC) With RB Therapy in Elderly Patients With Mentle Cell Lymphoma
A Phase 2 study testing RB/RBAC alternating and RB in people with Mantle Cell Lymphoma, run by Kim, Seok Jin at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- RB/RBAC alternating and RB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Oct 2022to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Gangnam-Gu, 06351
Seok Jin Kim, Ph.D, 82-2-3410-1766, seokjin88.kim@samsung.com
About this study
Official title: A Randomized Phase II Trial Comparing Rituximab/Bendamustine(RB) Alternating With Rituximab/Bendamustine/Cytarabine(RBAC) With RB as Induction Therapy in Elderly Patients With Newly Diagnosed and Transplant-ineligible Mantle Cell Lymphoma
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.
Read the detailed description
Eligible patients will be randomly assigned to either the investigational treatment arm (RB alternating with RBAC) or the standard treatment arm (RB) in a 1:1 ratio. Patients will be stratified by age (≥70 years vs. 60-69), histologic morphology (blastoid/pleomorphic vs. non-blastoid/non-pleomorphic), and MIPI-C risk score (0/1 vs. 2/3).
- Conditions
- Mantle Cell Lymphoma
- Being tested
- RB/RBAC alternating, RB
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RB/RBAC alternatingDrug
Patients assigned to the RB alternating with RBAC arm will receive six cycles of alternating RB (odd cycles) or RBAC (even cycles)
RB (1st, 3rd, and 5th cycles)
- Rituximab 375mg/m2, IV, D1
- Bendamustine 90mg/m2, IV, D1-2
RBAC (2nd, 4th, and 6th cycles)
- Rituximab 375mg/m2, IV, D1
- Bendamustine 70mg/m2, IV, D2-3
- Cytarabine 500mg/m2, IV, D2-4
RBDrug
Every 4 weeks for 6 cycles
- Rituximab 375mg/m2, IV, D1
- Bendamustine 90mg/m2, IV, D1-2
| Study group | Role | What they receive |
|---|---|---|
| RB/RBAC alternating | Experimental | Every 4 weeks for 6 cycles
RB (1st, 3rd, and 5th cycles)
* Rituximab + Bendamustine
RBAC (2nd, 4th, and 6th cycles)
* Rituximab + Bendamustine + Cytarabine Receives: Drug: RB/RBAC alternating |
| RB | Active comparator | Every 4 weeks for 6 cycles
- Rituximab + Bendamustine Receives: Drug: RB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-freesurvival
Measured: Up to 84 months
Secondary outcomes (5)
Overall Survival
Measured: Up to 84 months
Duration of Response
Measured: Up to 84 months
Event Free Survival
Measured: Up to 84 months
Overall response rate
Measured: Up to 84 months
Adverse events
Measured: From the day 1 of the clinical trial to 28 days after last drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start18 Oct 2022
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kim, Seok Jin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kim, Seok Jin, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245656
- Sponsor's protocol ID
- 2021-11-126
- Status last verified
- Apr 2026
- First submitted
- 8 Feb 2022
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial Comparing Rituximab/Bendamustine(RB) Alternating With Rituximab/Bendamustine/Cytarabine(RBAC) With RB as Induction Therapy in Elderly Patients With Newly Diagnosed and Transplant-ineligible Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT05245656
- Acronym / sponsor ID
- 2021-11-126
- Conditions
- Mantle Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kim, Seok JinUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eligible patients will be randomly assigned to either the investigational treatment arm (RB alternating with RBAC) or the standard treatment arm (RB) in a 1:1 ratio. Patients will be stratified by age (≥70 years vs. 60-69), histologic morphology (blastoid/pleomorphic vs. non-blastoid/non-pleomorphic), and MIPI-C risk score (0/1 vs. 2/3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RB/RBAC alternating | Experimental | Drug: RB/RBAC alternatingEvery 4 weeks for 6 cycles RB (1st, 3rd, and 5th cycles) * Rituximab + Bendamustine RBAC (2nd, 4th, and 6th cycles) * Rituximab + Bendamustine + Cytarabine |
| RB | Active comparator | Drug: RBEvery 4 weeks for 6 cycles - Rituximab + Bendamustine |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Written informed consent
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RB/RBAC alternatingPatients assigned to the RB alternating with RBAC arm will receive six cycles of alternating RB (odd cycles) or RBAC (even cycles) RB (1st, 3rd, and 5th cycles) * Rituximab 375mg/m2, IV, D1 * Bendamustine 90mg/m2, IV, D1-2 RBAC (2nd, 4th, and 6th cycles) * Rituximab 375mg/m2, IV, D1 * Bendamustine 70mg/m2, IV, D2-3 * Cytarabine 500mg/m2, IV, D2-4 | Drug | RB/RBAC alternating |
| RBEvery 4 weeks for 6 cycles * Rituximab 375mg/m2, IV, D1 * Bendamustine 90mg/m2, IV, D1-2 | Drug | RB |
Primary outcome
Progression-freesurvival
Time frame: Up to 84 months
5 secondary outcomes
Overall Survival
Time frame: Up to 84 months
Duration of Response
Time frame: Up to 84 months
Event Free Survival
Time frame: Up to 84 months
Overall response rate
Time frame: Up to 84 months
Adverse events
Time frame: From the day 1 of the clinical trial to 28 days after last drug administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RB/RBAC alternating and RB in people with Mantle Cell Lymphoma, run by Kim, Seok Jin at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact kim seok jin, phD (82-10-9933-1766, hjds.shin@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-freesurvival (time frame: Up to 84 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.