A Phase III Study Assessing Whether High-Dose Chemotherapy and Autologous Stem Cell Transplantation Improve Survival in Patients Who Have Mantle Cell Lymphoma with No Detectable Disease Using an Ultra-Sensitive Blood Test

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Full Title

NCI EA4151: 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 (CIRB)

Purpose

The usual treatment for mantle cell lymphoma (MCL) is initial chemotherapy, followed by maintenance therapy for several years with a drug called rituximab. In this study, researchers want to see if using high-dose chemotherapy and an autologous stem cell transplant (ASCT) after initial chemotherapy and before rituximab improves a patient’s survival. This study will include patients with MCL who show no detectable signs of cancer using an ultra-sensitive blood test that looks for “minimal residual disease” (MRD).

During ASCT, a patient’s own blood-forming stem cells are collected, and he or she is then treated with high doses of chemotherapy. Afterward, the collected stem cells are re-infused back into the patient to re-establish the blood-forming system.

Patients in this study will be randomly assigned to receive the usual treatment (initial chemotherapy followed by rituximab as maintenance therapy) or the study treatment (which includes the addition of ASCT after initial chemotherapy). Patients who still show some signs of lymphoma on their MRD test or who MRD test results are not clear may be able to participate in the study and receive ASCT plus standard treatment.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have MCL that is MRD-negative (complete remission) or MRD-positive after initial chemotherapy but in partial remission.
  • Patients must be about to begin or have completed initial chemotherapy within 4 months of entering the study, and must have achieved a complete or partial remission.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients ages 18 to 70.

For more information about this study and to inquire about eligibility, please contact Dr. Craig Sauter at 212-639-3460.

Protocol

18-066

Phase

III

Investigator

Co-Investigators