A Randomized Phase III Trial of Consolidation with Autologous Hematopoietic Cell Transplantation Followed by Maintenance Rituximab vs. Maintenance Rituximab Alone for Patients with Mantle Cell Lymphoma In Minimal Residual Disease-Negative First Complete Remission
Investigating Treatment Options for Mantle Cell Lymphoma (MCL) in First Complete Remission
Brief description of study.
The purpose of this study is to compare overall survival in MCL patients in MRD-negative first complete remission (CR) who undergo auto-HCT followed by maintenance rituximab vs. maintenance rituximab alone (without auto-HCT).
Detailed description of study
The purpose of this study is to compare overall survival in MCL patients in MRD-negative first complete remission (CR) who undergo auto-HCT followed by maintenance rituximab vs. maintenance rituximab alone (without auto-HCT).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Mantle Cell Lymphoma
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Age: 100 years or below
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Gender: All
Inclusion Criteria
Patients must have histologically confirmed mantle cell lymphoma, with documented cluster of differentiation (CD19) or CD20 expression and cyclin D1 (BCL1) by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescence in situ hybridization (FISH); the diagnosis must be confirmed by formal hematopathology review at the enrolling center, including assessment of Ki-67 proliferation index (=< 30% versus > 30% versus ?indeterminate? Ki-67 index)
Patients should be deemed to be potentially eligible and willing candidates for auto-HCT by the enrolling physician
For a full list of participation criteria, please visit clinicaltrials.gov.
This study investigates treatment options for patients with mantle cell lymphoma (MCL) who are in their first complete remission and are negative for minimal residual disease (MRD). The study compares two approaches: one group of patients will receive an autologous hematopoietic cell transplant (auto-HCT) followed by maintenance therapy, and the other group will receive maintenance therapy alone without the transplant. This research aims to determine which approach leads to better overall survival.
Participants in this study will either undergo a procedure known as an autologous hematopoietic cell transplant, where their own stem cells are used to replace damaged or destroyed bone marrow, or they will receive only maintenance therapy, which involves ongoing treatment to keep the cancer in remission. Maintenance therapy includes the use of rituximab, a medication that targets specific proteins on cancer cells. The study will monitor patients to assess the effectiveness of these treatments.
- Who can participate: Adults with confirmed mantle cell lymphoma in their first complete remission and candidates for autologous hematopoietic cell transplant may be eligible. Specific protein expressions must be confirmed through tests and assessed by a physician.
- Study details: Participants will receive either an autologous hematopoietic cell transplant followed by maintenance therapy or maintenance therapy alone. Maintenance therapy involves the use of rituximab, an investigational medication that targets cancer cells.