Study on Rituximab/Bendamustine and Rituximab/Cytarabine for Treating Mantle Cell Lymphoma
Sponsor: Dana-Farber Cancer Institute
ClinicalTrials ID:NCT01661881
This clinical trial is testing a new treatment approach for patients with newly diagnosed Mantle Cell Lymphoma (MCL) who are eligible for stem cell transplants. The study aims to improve treatment outcomes using a combination of drugs known to be effective against MCL.
Patient Parameters
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Program Overview
Mantle Cell Lymphoma (MCL) is a type of cancer that is difficult to cure with standard treatments. This study is exploring a new treatment plan for patients who have recently been diagnosed with MCL and are eligible for a stem cell transplant. The treatment involves using two drug combinations: Rituximab with Bendamustine, followed by Rituximab with Cytarabine. The goal is to increase the number of patients who achieve a complete response before undergoing a stem cell transplant, compared to past results.
Description
This study is designed to see if a new treatment plan using Rituximab with Bendamustine and Rituximab with Cytarabine is effective for patients with Mantle Cell Lymphoma (MCL) who are eligible for a stem cell transplant.
Primary Goal:
- To evaluate how well the treatment works by looking at the rate of complete responses (CR) and unconfirmed complete responses (CRu).
Secondary Goals:
- To assess the safety of the treatment.
- To estimate the rates of complete remission, partial remission, stable disease, and disease progression.
- To determine how many patients can successfully collect stem cells after the treatment.
- To find out how many patients can complete the treatment and proceed to a stem cell transplant.
- To estimate how well neutrophils and platelets recover after the transplant.
- To evaluate the response rates for patients with a specific type of MCL called blastoid variant.
- To measure the rate of minimal residual disease (MRD) negativity at the end of treatment.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of Mantle Cell Lymphoma by a specific hospital.
- Must have measurable disease that can be tracked.
- Must be eligible for a stem cell transplant.
Exclusion Criteria
- Cannot have received any previous treatment for lymphoma.
- Cannot be pregnant or breastfeeding.
- Cannot have an allergy to Rituximab.
- Cannot have any uncontrolled illnesses.
- Cannot be participating in other clinical trials.
- Cannot be HIV positive and on combination antiretroviral therapy.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Massachusetts General Hospital | 02113 | Boston | Massachusetts |
| Brigham and Women's Hospital | 02215 | Boston | Massachusetts |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
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