Stem Cell Transplant Offers No Additional Benefit for Patients with Mantle Cell Lymphoma in Deep Remission
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~ A recent study presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition has found that patients with mantle cell lymphoma (MCL) who have no detectable cancer after initial therapy do not experience any survival benefit from undergoing a stem cell transplant compared to receiving maintenance therapy alone.

The trial, known as EA4151, was stopped early after an interim analysis was conducted when the study had followed patients for a median of 2.7 years. The results showed that patients who tested negative for minimal residual disease (MRD) with an ultra-high sensitivity blood test did not need to undergo a stem cell transplant or the high-dose chemotherapy regimen typically used to prepare for a transplant.

Lead author of the study, Dr. Timothy S. Fenske, stated that these findings suggest that physicians can feel comfortable omitting the transplant in MRD-negative patients. He also noted that in today's treatment landscape for MCL, good outcomes can be achieved without the high-dose chemotherapy and transplant. However, for patients who remain MRD-positive following induction therapy, a stem cell transplant may still be considered.

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MCL is a rare and aggressive blood cancer that primarily affects older adults. After initial chemotherapy, doctors often recommend a stem cell transplant to further reduce the level of residual lymphoma. However, this practice is based on studies conducted before newer and more effective treatments such as chemotherapy, immune therapy, and targeted therapies were available.

The trial enrolled 650 patients between 2017-2024 who were in their first remission after initial treatment for MCL. The participants had a median age of 60 years and were predominantly male and white. Each patient's remission status was assessed using various tests including PET/CT scans, bone marrow biopsies, and highly sensitive blood tests.

The patients were then divided into three groups based on their test results: MRD-negative (no evidence of cancer), MRD-positive (evidence of cancer in one or more cells per million), or MRD-indeterminate (testing incomplete or evidence of cancer in greater than zero but less than one cell per million).

Of the 516 patients who tested MRD-negative, they were randomly assigned to receive either a stem cell transplant and three years of maintenance rituximab or three years of maintenance rituximab alone. The remaining patients (MRD-positive and MRD-indeterminate) were assigned to receive a stem cell transplant and three years of maintenance rituximab.

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The interim analysis showed no significant difference in overall survival rates between the two groups in the MRD-negative category. With a median follow-up of 2.7 years, the overall survival rate was 82.1% for those who received a stem cell transplant and 82.7% for those who received maintenance therapy alone. The rate of survival without disease progression was also similar between the two groups.

Dr. Fenske emphasized that a stem cell transplant can be a difficult process for patients, with potential complications being especially risky for older individuals. He believes that if similar outcomes can be achieved without undergoing a transplant, it would be a significant step forward in improving treatment for MCL.

In conclusion, this study suggests that for MCL patients who test negative for minimal residual disease after initial therapy, undergoing a stem cell transplant may not provide any additional survival benefit compared to receiving maintenance therapy alone. This finding may lead to changes in current treatment recommendations and improve outcomes for these patients.
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