The purpose of this study is to find out if getting a blood stem cell transplant with donor stem cells given over several days is better than getting a blood stem cell transplant with donor stem cells given over 1 day. We want to find out which procedure over will result in improved recovery of blood and immune function after transplant. When donor stem cells are given over various days in mice, the blood and immune system recovery is quicker.
This is a complex study that involves various interventions, Intervention #1: Donor Initial Stem Cell Collection; Intervention #2: Stem Cell Product Initial Processing Orders; Intervention #3 Patient Admission and Transplantation; Intervention #4: Stem cell infusion; Intervention #5: Post infusion follow up; Intervention #6: Off Study Patient and Donor Evaluation. Patients whose donor fails to collect the appropriate number of cells will receive all their cells as a bulk infusion. These patients will continue to receive a transplant on protocol but will be replaced until both arms have reached the target accrual.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
116
Undergo allogeneic hematopoietic stem cell transplant
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Median Time to Engraftment of Neutrophils
Determine the effects of fractionated vs. bulk stem cell infusions on neutrophil recovery as defined by number of days with an absolute neutrophil count of less than 500 neutrophils per micro liter and time to an absolute neutrophil count (ANC) of 500. Determing the median time to ANC of \>/= 0.5 x 10\^9/L
Time frame: Up to 100 weeks
Number of Participants Assessed for Toxicities
Participants will be assessed for toxicities with the NCI-Common Terminology for Adverse Events (CTCAE), version 4.0.
Time frame: 2 years
Median Time to Platelet Engraftment
The area under the hematopoietic recovery curve for the factors: ALC, CD4, CD8, and platelet count. The area under the curve will be computed based on recordings at days 30, 60, 100, 180, 365. Determine days to platelet engraftment by platelet count.
Time frame: Up to 365 days
Overall Survival
Percentage of participants alive at 24 months
Time frame: 24 months
Hematopoietic Function on Day 30
Determine the difference of CD4+ lymphocyte recovery between the two arms on day 30
Time frame: 30 days
Hematopoietic Function on Day 180
Determine the difference of CD4+ lymphocyte recovery between the two arms on day 180
Time frame: 180 days
Hematopoietic Function on Day 360
Determine the difference of CD4+ lymphocyte recovery between the two arms on day 360
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Time frame: 360 days