RecruitingPhase 3NCT06724237

Testing Whether High Dose Chemotherapy and Infusion of the Patients' Own Stem Cells Improves Survival in Patients With Peripheral T-cell Lymphoma Who Achieved a Complete Response at the End of the Initial Chemotherapy

A Randomized Phase III Study to Evaluate Benefits of Autologous Stem Cell Transplant in Patients With Peripheral T Cell Lymphoma That Achieved a First Complete Remission (CR1) Following Induction Therapy (PTCL-STAT)

Sponsor

Eastern Cooperative Oncology Group

Enrollment

294 participants

Start Date

Jan 30, 2025

Study Type

INTERVENTIONAL

Conditions

Peripheral T-Cell Lymphoma, Not Otherwise Specified Anaplastic Large Cell Lymphoma, ALK-negative Follicular Helper T-Cell Lymphoma Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type

Summary

This phase III trial compares the effect of high dose chemotherapy and the patients' own (autologous) stem cells to observation only in patients with peripheral T-cell lymphoma who achieved a complete response after initial chemotherapy. Usual treatment after a complete response may include observation or high dose chemotherapy followed by an autologous stem cell transplant, however, it is not known if a transplant if beneficial. Giving chemotherapy before a stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Stem cells removed prior to treatment are then returned to the patient to replace the blood forming cells that were destroyed by the chemotherapy. Giving high dose chemotherapy followed by an autologous stem cell transplant may be more effective compared to observation only in treating patients with peripheral T-cell lymphoma who have achieved a complete response after initial chemotherapy.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Autologous Hematopoietic Stem Cell Transplantation, Best Practice, and others for people with anaplastic large cell lymphoma, alk-negative, follicular helper t-cell lymphoma, and other related conditions. The study is currently recruiting participants at 158 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAutologous Hematopoietic Stem Cell Transplantation

Undergo ASCT

OTHERBest Practice

Receive standard of care observation

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration and biopsy

PROCEDUREBone Marrow Biopsy

Undergo bone marrow aspiration and biopsy

PROCEDUREComputed Tomography

Undergo CT or PET/CT

DRUGHigh Dose Chemotherapy

Receive high dose chemotherapy

PROCEDURELeukapheresis

Undergo leukapheresis

PROCEDUREPositron Emission Tomography

Undergo PET/CT

DRUGStem Cell Mobilization Therapy

Receive stem cell mobilization therapy