PCRC_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

This randomized 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. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer 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.

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)
• Institution has received results from Adaptive Biotechnologies as defined by one of the following criteria:
Patients are ?MRD Indeterminate?: ClonoSEQ ID molecular marker assessment did not identify any unique clonal immunoglobulin DNA sequence OR ClonoSEQ ID molecular marker assessment identified unique clonal immunoglobulin DNA sequence and MRD assessment is completed
• Patients must have completed induction therapy within 120 days prior to preregistration to step 0, AND no more than 300 days may have elapsed from the first dose of induction chemotherapy given, until the last day of induction chemotherapy administered; for those assigned to Arms A, C, or D, the date of transplant must not be greater than 365 days after the first dose of induction chemotherapy given
-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 have achieved a radiologic complete or partial remission as defined by the Lugano criteria
• Patients must meet institutional eligibility requirements for stem cell transplant, including cardiac, renal, liver, and pulmonary requirements
• Patients have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Human immunodeficiency virus (HIV) positive patients are not excluded, but to enroll, must meet all of the criteria:
-HIV is sensitive to antiretroviral therapy, Must be willing to take effective antiretroviral therapy if indicated
-CD4 count at screening >= 300 cells/mm^3
-No history of acquired immune deficiency syndrome (AIDS)-defining conditions
• Patient must be disease-free >= 3 years of prior malignancies with the exception of adequately treated non-melanoma skin cancer, adequately treated in situ carcinoma, low grade prostate carcinoma (Gleason grade =< 6) managed with observation that has been stable for at least 6 months
• Women must not be pregnant or breast-feeding
• Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study
Phase III
NCT03267433
Oncology
Hematologic
Alison Conlin, M.D.
ECOG-ACRIN
Neysa Dagostino

The Pacific Cancer Research Consortium clinical trials are offered at multiple locations throughout Oregon, Washington, Alaska, California, and Idaho. To find a location near you, please contact the Patient Engagement Center at 844-552-2734.