Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a two arm open label phase III clinical trial. Adult patients with hematological malignancies undergoing allogeneic HSCT from any donor are eligible for the study if they meet the standard criteria defined in the investigator's institutional standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Patients will receive reduced-intensity conditioning regimen of fludarabine, busulfan (treosulfan). Patients will receive PTCy at different dose (25 mg/kg/day vs 50 mg/kg/day on day +3,+4 in combination with calcineurin inhibitors and mofetil mycophenolate) as GvHD prophylaxis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclophosphamide on day +3,+4 at dose 50 mg/kg/day | Active Comparator | Post-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 50 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5. |
|
| Cyclophosphamide on day +3,+4 at dose 25 mg/kg/day | Experimental | Post-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 25 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Post-transplantation Cyclophosphamide at dose 25 mg/kg/day | Drug | Post-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 25 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute graft-versus-host disease, grades II-IV | MAGIC criteria | 180 days |
| Incidence of chronic GVHD, moderate and severe (NIH criteria) | NIH criteria | 365 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival analysis | Kaplan-Meier survival analysis | 365 days |
| Event-free survival analysis | Kaplan-Meier survival analysis | 365 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mikhail Drokov, MD, Ph.D | Contact | +74956149042 | mdrokov@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Elena Parovichnikova, MD, D.Sc | National Research Center for Hematology | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Post-transplantation Cyclophosphamide at dose 50 mg/kg/day | Drug | Post-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 50 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5. |
|
|
| Non-relapse mortality analysis | Kaplan-Meier survival analysis, competing risk analysis | 365 days |
| Incidence of graft failure and poor graft function | Kaplan-Meier survival analysis, competing risk analysis | 365 days |
| Incidence of 30-Day Readmission | Kaplan-Meier survival analysis, competing risk analysis | 365 days |
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C559940 | trihexyltetradecylphosphonium chloride |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
Not provided
Not provided