This pilot trial studies different high-dose chemotherapy regimens with or without total-body irradiation (TBI) to compare how well they work when given before autologous stem cell transplant (ASCT) in treating patients with hematologic cancer or solid tumors. Giving high-dose chemotherapy with or without TBI before ASCT stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood or bone marrow and stored. More chemotherapy may be given to prepare for the stem cell transplant. The stem cells are then returned to the patient to replace the blood forming cells that were destroyed by the chemotherapy.
PRIMARY OBJECTIVES: I. Estimate the progression free survival (PFS) distribution for Hodgkin lymphoma (HL), non-Hodgkin lymphoma (NHL) and multiple myeloma (MM) for each disease-specific high dose therapy regimen. SECONDARY OBJECTIVES: I. Estimate the PFS distribution for amyloidosis, acute leukemia and selected solid tumors for each disease-specific high dose therapy regimen. II. Explore the role of risk factors in the outcome of all treated patients. III. Examine the high dose therapy regimen-related toxicity (RRT) and overall survival after bone marrow transplant (BMT). OUTLINE: Patients are assigned to conditioning regimens based on disease, age, and co-morbidities.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
174
Given IV
Given IV
Given IV
Given IV
Given IV
Given IV
Given IV
Undergo TBI
Undergo ASCT
Undergo tandem ASCT
Roswell Park Cancer Institute
Buffalo, New York, United States
Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors)
Assessed using the product-limit based Kaplan Meier method. Additionally, a 95% confidence interval of the distribution will be computed.
Time frame: From the date of transplantation to the date of first observed disease progression or death due to any cause, assessed up to 12 years
Regimen-related Toxicity Grade 2-4 in Any Organ (Measured by Bearman Score, Values Range From 0 (None) to 4 (Fatal))
Toxicities will be reported using descriptive statistics.
Time frame: Up to 100 days after transplantation
Response Rate (Complete Remission)
Response rates will be reported using descriptive statistics.
Time frame: At 100 days
Overall Survival, Presented as the Estimate at 10-yrs (Median Follow-up Time in Survivors)
Assessed using the product-limit based Kaplan Meier method.
Time frame: Patients are followed up to maximum of 12 years
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