Rituximab + Stem Cell Transplant for Mantle Cell Lymphoma

Not currently recruiting at 419 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: ECOG-ACRIN Cancer Research Group

Must be taking: Rituximab

Disqualifiers: CNS involvement, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of rituximab in treating mantle cell lymphoma, a cancer affecting the lymph nodes. Researchers aim to determine if rituximab, when used after autologous hematopoietic stem cell transplantation, is more effective than rituximab alone. The trial includes two groups: one receiving rituximab with a stem cell transplant and the other receiving rituximab without the transplant. Individuals diagnosed with mantle cell lymphoma who responded well to initial treatment might be suitable for this study. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it allows for up to two regimens of therapy, including conventional chemotherapy, antibody therapy, or an oral regimen, as long as a continuous response was ongoing throughout therapy.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that rituximab, a common treatment for mantle cell lymphoma, is usually well-tolerated. Studies have found that patients live longer when rituximab is added to chemotherapy. Most people experience mild to moderate side effects like fever, chills, or tiredness, while more serious reactions occur less frequently.

For autologous hematopoietic stem cell transplantation (auto-HCT), research indicates it can be an effective and safe treatment for mantle cell lymphoma. This treatment uses a person's own stem cells to aid recovery from high-dose chemotherapy. Some people may experience side effects like infections or bleeding, but these are expected and manageable.

Overall, both rituximab and auto-HCT have been tested in many people and are safe for most. Discussing potential risks and benefits with healthcare providers is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination treatment of rituximab and stem cell transplants for mantle cell lymphoma because it offers a potentially more effective approach than current therapies. While standard treatments rely heavily on chemotherapy and monoclonal antibodies alone, this trial combines rituximab with an autologous stem cell transplant, aiming to enhance the body's ability to fight the cancer. Rituximab targets specific proteins on cancer cells, and when used alongside a stem cell transplant, it may improve remission rates and prolong survival. Additionally, the study explores different delivery methods, such as subcutaneous administration with hyaluronidase, which could offer more convenience and potentially fewer side effects compared to traditional intravenous infusion.

What evidence suggests that rituximab with or without stem cell transplant might be an effective treatment for mantle cell lymphoma?

Studies have shown that adding rituximab to chemotherapy helps patients with mantle cell lymphoma live longer. In this trial, participants in Group II will receive rituximab following standard chemotherapy. Real-world data confirms that rituximab maintenance improves survival and controls the disease in older patients with this condition. Research further indicates that rituximab maintenance extends the time patients live without disease progression and improves overall survival.

Participants in Group I will undergo autologous hematopoietic stem cell transplantation followed by rituximab. Evidence on autologous hematopoietic stem cell transplantation shows mixed results. Some studies find no extra survival benefit compared to maintenance therapy alone. However, stem cell transplants remain important for certain patients, depending on their health needs and response to previous treatments. ^{4 6 7 8 9}

Who Is on the Research Team?

Timothy S Fenske

Principal Investigator

ECOG-ACRIN Cancer Research Group

Are You a Good Fit for This Trial?

This trial is for patients with mantle cell lymphoma in first complete remission and no minimal residual disease. Candidates must have completed certain therapies, be eligible for stem cell transplant, and not have CNS involvement by the lymphoma. HIV+ individuals can join if they meet specific health criteria. Pregnant or breastfeeding women are excluded, as well as those with recent other cancers or without a confirmed diagnosis.

Inclusion Criteria

Institution has received results from Adaptive Biotechnologies as defined by one of the following criteria

I have completed at least 4 cycles of initial cancer treatment.

I am not pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Induction Chemotherapy

Patients receive standard of care induction chemotherapy

6-8 weeks

Weekly visits (in-person)

Stem Cell Transplantation and Maintenance Rituximab

Patients undergo autologous hematopoietic stem cell transplantation followed by maintenance rituximab

18 cycles of rituximab every 8 weeks

Every 8 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

Every 3 to 6 months (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Autologous Hematopoietic Stem Cell Transplantation
• Rituximab

Trial Overview The study compares rituximab effectiveness after a stem cell transplant versus rituximab alone in treating mantle cell lymphoma that's in remission. It looks at how these treatments affect cancer cells' growth and spread, involving chemotherapy to prepare for the patient's own collected stem cells to be transplanted back into their body.

How Is the Trial Designed?

Group I: Group II (rituximab) Experimental Treatment 7 Interventions

Patients receive standard of care induction chemotherapy. Beginning 40-180 days after completion of chemotherapy, patients receive rituximab or rituximab and hyaluronidase human or any approved rituximab biosimilar at the approved dose, as in Group I. Patients undergo PET, CT or PET/CT throughout the study. Patients may undergo blood sample collection during screening and on study. Patients also may undergo bone marrow biopsy and aspirate during screening.

Group II: Group I (auto-HCT, rituximab) Experimental Treatment 8 Interventions

Patients receive standard of care preparative chemotherapy and undergo auto-HCT. Beginning 100-140 days after transplant, patients receive rituximab IV or rituximab and hyaluronidase human SC or any approved rituximab biosimilar at the approved dose once every 8 weeks for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET, CT or PET/CT throughout the study. Patients may undergo blood sample collection during screening and on study. Patients also may undergo bone marrow biopsy and aspirate during screening.

Rituximab is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Rituxan for:

• Non-Hodgkin's lymphoma
• Chronic lymphocytic leukemia
• Rheumatoid arthritis
• Granulomatosis with polyangiitis
• Microscopic polyangiitis

Approved in European Union as MabThera for:

• Non-Hodgkin's lymphoma
• Chronic lymphocytic leukemia
• Rheumatoid arthritis
• Granulomatosis with polyangiitis
• Microscopic polyangiitis

Approved in Canada as Rituxan for:

• Non-Hodgkin's lymphoma
• Chronic lymphocytic leukemia
• Rheumatoid arthritis
• Granulomatosis with polyangiitis
• Microscopic polyangiitis

Who Is Running the Clinical Trial?

ECOG-ACRIN Cancer Research Group

Lead Sponsor

Trials

122

Recruited

160,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 14 patients with follicular or mantle-cell lymphoma, a high incidence of neutropenia was observed in those treated with rituximab before and after autologous stem cell transplantation (ASCT).

The findings highlight the potential safety concern of neutropenia associated with rituximab treatment in the context of high-dose therapy and stem cell transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High incidence of neutropenia in patients treated with rituximab after autologous stem cell transplantation. Cairoli, R., Grillo, G., Tedeschi, A., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12350992/

Stem cell transplantation outcomes in mantle cell lymphoma Here, we retrospectively analyzed the long-term survival outcomes of patients with MCL who underwent auto- or allo-SCT as consolidation or ...

2. hematology.org hematology.org/newsroom/press-releases/2024/stem-cell-transplant-offers-no-additional-benefit

Stem Cell Transplant Offers No Additional Benefit Transplant shows no difference in overall or progression-free survival compared with maintenance therapy alone.

3. ashpublications.org ashpublications.org/blood/article/140/Supplement%201/6517/492137/Clinical-Outcomes-in-Patients-with-Mantle-Cell

Clinical Outcomes in Patients with Mantle Cell Lymphoma ... Two (11%) patients did not have an adequate response to 2L induction therapy, and 1 (6%) patient did not meet criteria due to failure of the ...

4. astctjournal.org astctjournal.org/article/S1083-8791(04)00509-9/fulltext

Outcomes of autologous and allogeneic blood or marrow ... At 3 years, the estimated EFS for the entire cohort after BMT was 51%, the probability of relapse was 31%, and the overall survival was 59%. The benefit of ...

5. nature.com nature.com/articles/s41409-025-02599-x

How we treat mantle cell lymphoma with cellular therapy in ... The purpose of this paper is to give some guidance regarding how to best use cellular therapies in this increasingly complex environment.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9302266/

Long-Term Outcomes and Safety Trends of Autologous Stem ... Upfront consolidation with ASCT improves the duration of response in aggressive subtypes such as mantle-cell lymphoma (6-year OS and EFS; 70% ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3934030/

Autologous stem cell transplantation for mantle ... High-dose chemotherapy followed by autologous stem cell transplantation (ASCT) may result in higher progression-free (PFS) and overall survival (OS) when used ...

8. astctjournal.org astctjournal.org/article/S2666-6367(21)00744-2/fulltext

American Society of Transplantation and Cellular ... Consolidative autologous hematopoietic cell transplantation is recommended in the first-line treatment of patients with mantle cell lymphoma (MCL) in complete ...

9. link.springer.com link.springer.com/article/10.1007/s12672-025-01876-x

a meta-analysis | Discover Oncology This work aimed to establish meta-analysis to methodically evaluate the safety and effectiveness of autologous stem cell therapy (AHSCT) in the ...