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)

Description
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.

Objective
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 cell transplant (ASCT) arm.

EXPLORATORY OBJECTIVE:

I. To determine the impact of minimal residual disease (MRD) on the benefit of autologous stem cell transplant (ASCT).

Treatment OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive standard of care observation on study. Patients also undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and computed tomography (CT) or positron emission tomography (PET)/CT throughout the study.

ARM II: Patients receive stem cell mobilization and then undergo leukapheresis per standard of care. Patients also receive high dose chemotherapy followed by ASCT per standard of care. Additionally, patients undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and CT or PET/CT throughout the study.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for up to 7 years for a total of 12 years from the date of randomization.

Official Title

Key Eligibility For full study eligibility, see this study's ClinicalTrials.gov record.

Applicable Disease Sites
Lymphoma

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital