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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced-Dose Post-Transplant Cyclophosphamide, Abatacept, and Short-Duration Tacrolimus | Experimental | Participants to receive:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | Nitrogen mustard alkylating agent produced by Bristol-Myers Squibb. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Day 120 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Day 365 |
| Number of Participants Presenting with Primary Graft Failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammad Maher Abdul Hay | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Only available to study team members.
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D000069594 | Abatacept |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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|
| Abatacept | Drug | Calcineurin-inhibitor produced by Astellas. |
|
|
| Tacrolimus | Drug | Selective T cell co-stimulation modulator produced by Bristol-Myers Squibb. |
|
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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. |
| 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. | 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%. | Up to Day 730 |
| Treatment-Related Mortality (TRM) Rate | The proportion of participant deaths not attributable to disease relapse or progression. | 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. | 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. | Up to Day 730 |
| Overall Survival (OS) Rate | The proportion of participants who are alive at the end of the study's evaluation period. | Up to Day 730 |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
| D018942 | Macrolides |
| D007783 | Lactones |