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.
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). 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
294
Undergo ASCT
Receive standard of care observation
Undergo blood sample collection
Undergo bone marrow aspiration and biopsy
Undergo bone marrow aspiration and biopsy
Undergo CT or PET/CT
Receive high dose chemotherapy
Undergo leukapheresis
Undergo PET/CT
Receive stem cell mobilization therapy
Progression-free survival (PFS)
Stratified logrank test will be used for the primary analysis of the comparison of PFS between treatment arms. Kaplan-Meier method will be used to visualize and estimate survival function for failure time endpoints. There will be a subgroup analysis for the randomization stratification factors, and other variables measured at baseline.
Time frame: From study randomization to documented disease progression or death, whichever occurs first, assessed up to 12 years
Overall survival (OS)
Stratified logrank test will be used for the primary analysis of the comparison of OS between treatment arms. Kaplan-Meier method will be used to visualize and estimate survival function for failure time endpoints. There will be a subgroup analysis for the randomization stratification factors, and other variables measured at baseline.
Time frame: From study randomization to death due to any cause, assessed up to 12 years
Cumulative incidence of relapse
The cumulative incidence of relapse will be analyzed under the competing risk framework using competing risk regression and competing risk cumulative incidence function plots.
Time frame: Up to 12 years
Cumulative incidence of mortality
The cumulative incidence of mortality will be analyzed under the competing risk framework using competing risk regression and competing risk cumulative incidence function plots.
Time frame: Up to 12 years
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