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Protocol No. EA4151

Principal Investigator Kenkre, Vaishalee

Phase III

Age Group Adult

Scope National

Sponsor Type National

Title A Randomized Phase III Trial of Consolidation with Autologous Hematopoietic Cell Transplantation Followed by Maintenance Cell Rituximab vs. Maintenance Rituximab Alone for Patients with Mantle Cell Lymphoma in Minimal Residual Disease-Negative First Complete Remission

Objective The purpose of this research study is to determine whether an autotransplant improves survival in MCL patients who have achieved an excellent (MRD-negative) first complete remission (CR). This study uses a recently developed ultra-sensitive technique called a “minimal residual disease” (or MRD) analysis to detect extremely small amounts of residual lymphoma cells in the blood. A patient who is thought to be in remission by traditional testing methods (such as CT scans, PET scans, bone marrow biopsy, or routine blood tests) may still remain positive by the MRD test since it is so sensitive. The ultrasensitive blood test (MRD test) is considered a “biomarker.” Researchers believe that this test will allow for a more reliable way to decide who should undergo autotransplant in first remission.

Treatment
Only patients who are MRD-negative first complete remission may be assigned to Groups 1 and 2

Group 1: You will be assigned autotransplant. You will complete the initial chemotherapy as prescribed by your cancer physician. You will then undergo high-dose chemotherapy and autotransplant, followed by 3 years of maintenance rituximab

Group 2: You will be assigned to not receive autotransplant. You will complete the initial chemotherapy as prescribed by your cancer physician. You will then undergo 3 years of maintenance rituximab

Groups 3 and 4: You will be assigned to this group if you are in partial remission (PR), MRD indeterminate and/or your MRD test is still positive for lymphoma after initial chemotherapy. You will complete the initial chemotherapy as prescribed by your cancer physician. You will then undergo high-dose chemotherapy and autotransplant, followed by three years of maintenance rituximab

Description Randomized study testing whether high-dose chemotherapy and infusion of the patient’s own blood stem cells improves survival in mantle cell lymphoma patients with no detectable lymphoma using an ultra-sensitive blood test for residual lymphoma

Key Eligibility
  • Histologically confirmed mantle cell lymphoma
  • Patients should be deemed to be potentially eligible and willing candidates for autotransplant
  • Up to two regimens of chemotherapy are allowed as long as a continuous response was ongoing throughout therapy
  • Patient does not have any documented history of central nervous system (CNS) involvement by mantle cell lymphoma
  • Patient must have received at least four (4) cycles of induction therapy
  • Up to two regimens of chemotherapy are allowed as long as a continuous response was ongoing throughout therapy
  • Patients must be eligibility for stem cell transplant, including cardiac, renal, liver, and pulmonary requirements
  • ECOG PS 0-2

  • Applicable Disease Sites Lymphoma

    Status Open

    Participating Institutions UW Hospital and Clinics