Patients with mantle cell lymphoma are needed for a research study on the effects of having an autotransplant

IRB/UVA Tracking #
20317
Principal Investigator
Craig A Portell
Contact
Erica Stallard
Contact Email
Contact Phone
434.243.2649
Official Trial 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 R
Study Description

The University of Virginia Cancer Center is conducting a clinical research study for adult patients with mantle cell lymphoma ages 18 and over who have achieved an excellent minimal residual disease-negative first complete remission. 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 research study has three study groups and patients will be randomly assigned to a group.

Group 1: You will be assigned autotransplant and then initial chemotherapy as prescribed by your cancer physician. You will then undergo high-dose chemotherapy and autotransplant, followed by 3 years of maintenance rituximab. You will receive rituximab every 8 weeks for approximately 3 years.

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. You will receive rituximab every 8 weeks for approximately 3 years.

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. You will receive rituximab every 8 weeks for approximately 3 years.
Follow-up after treatment could last up to 10 years. Study-specific tests that take place beyond your usual care will be provided at no cost to you or your insurance.

Additional information is available here: https://clinicaltrials.gov/ct2/show/NCT03267433

Compensation

You will not be paid for taking part in this study.