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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
Sponsor: Eastern Cooperative Oncology Group
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
294
Start Date
2024-12-01
Completion Date
2033-12-01
Last Updated
2024-12-09
Healthy Volunteers
No
Conditions
Interventions
Autologous Hematopoietic Stem Cell Transplantation
Undergo ASCT
Best Practice
Receive standard of care observation
Biospecimen Collection
Undergo blood sample collection
Bone Marrow Aspiration
Undergo bone marrow aspiration and biopsy
Bone Marrow Biopsy
Undergo bone marrow aspiration and biopsy
Computed Tomography
Undergo CT or PET/CT
High Dose Chemotherapy
Receive high dose chemotherapy
Leukapheresis
Undergo leukapheresis
Positron Emission Tomography
Undergo PET/CT
Stem Cell Mobilization Therapy
Receive stem cell mobilization therapy