Rituximab With or Without Stem Cell Transplant in Treating Patients With Minimal Residual Disease-Negative Mantle Cell Lymphoma in First Complete Remission

Conditions

• Mantle Cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Autologous Hematopoietic Stem Cell Transplantation — PROCEDURE
  Undergo HCT
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Bone Marrow Aspirate — PROCEDURE
  Undergo bone marrow biopsy and aspirate
• Bone Marrow Biopsy — PROCEDURE
  Undergo bone marrow biopsy and aspirate
• Computed Tomography — PROCEDURE
  Undergo CT or PET/CT
• Positron Emission Tomography — PROCEDURE
  Undergo PET or PET/CT
• Rituximab — BIOLOGICAL
  Given IV
• Rituximab and Hyaluronidase Human — BIOLOGICAL
  Given SC

Study Details

This phase III trial studies rituximab after stem cell transplant and to see how well it works compared with rituximab alone in treating patients with in minimal residual disease-negative mantle cell lymphoma in first complete remission. Immunotherapy with rituximab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving rituximab with or without stem cell transplant may work better in treating patients with mantle cell lymphoma.

Key Dates

Start date

Nov 27, 2017

Status verified

Apr 2026

Primary completion

Jan 31, 2027

Completion

Jan 31, 2027

Study Design

Enrollment

689 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group I (auto-HCT, rituximab)
  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.
• Experimental: Group II (rituximab)
  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.

Primary Outcome Measure

Overall survival (OS) in mantle cell lymphoma (MCL) patients in minimal residual disease (MRD)-negative complete remission (CR) who undergo auto-hematopoietic stem cell transplant (HCT) followed by rituximab versus (vs.) maintenance rituximab alone [ Time Frame: Time between randomization and death from any cause, assessed up to 10 years ]

Locations (374)

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