Study on Rituximab With or Without Stem Cell Transplant for Treating Patients with Minimal Residual Disease-Negative Mantle Cell Lymphoma in First Complete Remission

Sponsor: ECOG-ACRIN Cancer Research Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03267433

Provider View

This clinical trial is exploring whether adding a stem cell transplant to rituximab treatment is more effective than rituximab alone for patients with mantle cell lymphoma who are in their first complete remission and have no minimal residual disease.

Patient Parameters

Program Overview

This study is investigating if combining rituximab with a stem cell transplant is more effective than using rituximab alone in treating patients with mantle cell lymphoma who are in their first complete remission and have no minimal residual disease. Rituximab is a type of monoclonal antibody that may help stop cancer cells from growing and spreading. The process involves using chemotherapy to kill cancer cells and make space in the bone marrow for new stem cells. These stem cells are collected, stored, and then returned to the patient after more chemotherapy. The study aims to see if this combination can improve treatment outcomes.

Description

The main goal of this study is to compare the overall survival of patients with mantle cell lymphoma who receive a stem cell transplant followed by rituximab maintenance therapy, versus those who receive rituximab maintenance therapy alone. Secondary goals include comparing the time patients remain free from cancer progression, understanding survival rates at 2 and 5 years for patients with some remaining disease, and examining the rate of complications like infections or hospitalizations.

Participants are divided into two groups:

  • Group I: Patients receive chemotherapy and a stem cell transplant. After 60-120 days, they receive rituximab every 8 weeks for up to 18 doses, unless the disease progresses or side effects are too severe.
  • Group II: Patients receive chemotherapy and then rituximab as in Group I, starting 40-120 days after chemotherapy.

After treatment, patients are monitored every 3 to 6 months for up to 10 years.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of mantle cell lymphoma with specific genetic markers.
  • Must be eligible and willing to undergo a stem cell transplant.
  • May be receiving or have completed initial therapy within 60 days before joining the study.
  • Must not have any history of cancer spreading to the brain or spinal cord.
  • Must have a tumor sample available for specific testing.
  • Must have completed initial therapy within 120 days before joining the study.
  • Must have achieved a complete or partial remission based on specific criteria.
  • Must meet health requirements for stem cell transplant, including heart, kidney, liver, and lung function.
  • Must have a performance status score of 0-2, indicating good overall health.
  • HIV-positive patients can join if they meet specific health criteria.
  • Must be free of other cancers for at least 3 years, except for certain skin or prostate cancers.
  • Women must not be pregnant or breastfeeding and must use effective contraception if of childbearing potential.
  • Men must use effective contraception or abstain from sex during the study.

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