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

Recruiting
100 years or below
All
Phase N/A
1 Location

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
  • Age: 100 years or below
  • 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.

Updated on 04 Aug 2024. Study ID: 1804274223 (EA4151/BMTCTN1601)

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