This is a single arm, open label, phase II clinical trial. Adult patients with hematological malignancies undergoing allogeneic HSCT from first- or second-degree haploidentical donor are eligible for the study if they meet the standard criteria defined in our institutional standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Patients will receive non-myeloablative, reduced-intensity or myeloablative conditioning regimen followed by peripheral blood hematopoietic stem cells. Patients will receive dosed reduced cyclophosphamide, abatacept, and short-duration tacrolimus for GvHD prophylaxis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
27
Nitrogen mustard alkylating agent produced by Bristol-Myers Squibb.
Calcineurin-inhibitor produced by Astellas.
Selective T cell co-stimulation modulator produced by Bristol-Myers Squibb.
NYU Langone Health
New York, New York, United States
Cumulative Incidence of Grades II-IV Acute GvHD
The first day of acute GvHD of any grade is used to calculate the cumulative incidence for that grade. The diagnosis of acute GvHD is based on clinical and pathological evaluation by the principal investigator in collaboration with the treating physician.
Time frame: Up to Day 120
Cumulative Incidence of Chronic GvHD
The first day of chronic GvHD is used to calculate the cumulative incidence of chronic GvHD. The diagnosis of chronic GvHD is based on clinical and pathological evaluation by the principal investigator in collaboration with the treating physician.
Time frame: Up to Day 365
Number of Participants Presenting with Primary Graft Failure
Primary graft failure is defined as failure to achieve neutrophil engraftment by Day 28 after transplant or lack of donor chimerism greater than 50% by Day 45, not due to the underlying malignancy.
Time frame: Up to Day 45
Number of Participants Presenting with Poor Graft Function
Poor graft function is defined by at least 2 of the following 3 criteria: Hemoglobin less than 8 g/dL, absolute neutrophil count less than 0.5 x 109/L, and platelets less than 20 x 109/L. The cytopenia must be unexplained (such as by disease relapse) and unresponsive to cytokines and must last at least 4 weeks.
Time frame: Up to Day 30
Number of Participants Presenting with Secondary Graft Failure
Secondary graft failure is defined as poor graft function associated with donor chimerism less than 5%.
Time frame: Up to Day 730
Treatment-Related Mortality (TRM) Rate
The proportion of participant deaths not attributable to disease relapse or progression.
Time frame: Up to Day 730
Relapse Rate (RR)
The proportion of participants in whom the disease for which transplant was performed is evident by methods of disease detection.
Time frame: Up to Day 730
GvHD and Relapse-Free Survival (GRFS) Rate
The proportion of participants who are without reported grade III-IV acute GvHD, chronic GvHD requiring systemic therapy and have not experienced relapse or death.
Time frame: Up to Day 730
Overall Survival (OS) Rate
The proportion of participants who are alive at the end of the study's evaluation period.
Time frame: Up to Day 730
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