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)
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.
Description
PRIMARY OBJECTIVE: I. To demonstrate improvement in progression free survival (PFS) in the autologous stem cell transplant (ASCT) arm compared to the observation arm. SECONDARY OBJECTIVES: I. To assess difference in overall survival (OS) between the observation and autologous stem cell transplant (ASCT) arm. II. To evaluate the differences in study intervention benefit for PFS and OS by the randomization stratification factors (histology and choice of induction chemotherapy). III. To evaluate the cumulative incidence of relapse and mortality between the observational and autologous stem c…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patient must be 18 to 75 years of age * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Patient must have histologically proven peripheral T-cell lymphoma (PTCL) in one of the following categories: * Anaplastic large cell lymphoma (ALCL) ALK-negative * Angioimmunoblastic T-cell lymphoma (AITL) * Nodal PTCL with follicular helper T cell (TFH) phenotype * Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) * Patient must have undergone induction treatment with an anthracycline based chemotherapy. * NOTE: Patient…
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
Location
- Alaska Breast Care and Surgery LLCAnchorage, Alaska