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Clinical Trial 19627

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT03267433

Phase: Phase III
Principal Investigator: Liu, Hien

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

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

Summary

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.

Objective

Primary: 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 autoHCT). Secondary: To compare progression-free survival in MCL patients in MRDnegative CR who undergo auto-HCT followed by maintenance rituximab vs. maintenance rituximab alone. To define the overall survival and progression-free survival at 2 and 5 years of chemosensitive but MRD-positive CR patients who undergo auto-HCT followed by 3 years of maintenance rituximab. To define the overall survival and progression-free survival at 2 and 5 years of chemosensitive but MRD-positive PR patients who undergo auto-HCT followed by 3 years of maintenance rituximab. To define the overall survival and progression-free survival at 2 and 5 years of MRD-negative PR patients who undergo auto-HCT followed by 3 years of maintenance rituximab. To define the overall survival and progression-free survival at 2 and 5 years of MRD-indeterminate patients who undergo auto-HCT followed by 3 years of maintenance rituximab. To describe the rate of complications (serious infection, hospitalization, need for intravenous immune globulin) in MCL patients undergoing maintenance rituximab following auto-HCT. To determine the prognostic impact of MRD status at day 100, in MCL patients who were MRD-positive (including MRD-positive CR and MRD-positive PR) prior to auto-HCT

Treatments

Therapies

Therapy (NOS)

Medications

Rituxan (rituximab); Rituxan Hycela (); rituximab ()

Inclusion Criteria

> INCLUSION CRITERIA FOR SCREENING

Participants must have histologically confirmed mantle cell lymphoma,with cyclin D1 by immunohistochemical stains and/or t(11;14) by cytogenetics or FISH. If patient has cyclin D1 negative mantle cell lymphoma with classical morphology and an expression profile that is otherwise indistinguishable from mantle cell lymphoma, communication with investigator is required for consideration of enrollment. The proliferation rate, using Ki-67 or MIB-1,should also be determined, but is not required until Step 1 registration. Participants may register to Step 0 without a documented Ki-67 index.

Participants should be deemed to be potentially eligible and willing candidates for auto-HCT by the enrolling physician.

Participant may be receiving or have completed induction therapy within 60 days prior to preregistration to step 0; no more than 300 days may have passed between the first day of induction therapy and preregistration to step 0.

Does not have documented history of central nervous system (CNS) involvement by mantle cell lymphoma.

Participant must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen from the original diagnostic biopsy available for submission to Adaptive Biotechnologies for ClonoSEQ ID molecular marker identification of unique clonal immunoglobulin deoxyribonucleic acid (DNA) sequence.

INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1)

Participants must have met eligibility criteria for the screening step

Institution has received results from Adaptive Biotechnologies as defined by one of the following criteria: Participants 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

Participants must have completed induction therapy within 150 days prior to registration to Step 1, AND no more than 300 days may have elapsed from the first dose of induction chemotherapy (C1D1) given, until the last day of induction chemotherapy administered. For those assigned to Arms A, C, or D, the date of transplant ( Day 0 ) must not be greater than 365 days after the first dose of induction chemotherapy (C1D1) given.

Participant must have received at least four four (4) cycles of induction therapy

Up to two regimens of chemotherapy are allowed as long as a continuous response was ongoing throughout therapy

Participants must have achieved a radiologic complete or partial remission as defined by the Lugano criteria.

Participants must meet institutional eligibility requirements for stem cell transplant, including cardiac, renal, liver, and pulmonary requirements

Participants have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Human immunodeficiency virus (HIV) positive participants are not excluded, but to enroll, must meet all of the below criteria: HIV is sensitive to antiretroviral therapy, Must be willing to take effective antiretroviral therapy if indicated, No history of HIV-related opportunistic disease of AIDs defining conditions within past 12 months other than historic CD4+ T-cell counts below 200 cells/mm3, and Expected long-term survival if lymphoma were not present

Participant 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 => Women must not be pregnant or breast-feeding. Females of childbearing potential must have blood test or urine within 2 weeks prior to registration.

Women of childbearing potential and sexually active males must use an accepted and effective method of birth control.

Exclusion Criteria

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