Graft Versus Host Disease Clinical Trial
Official title:
Use of Post Transplant Cyclophosphamide as Graft Versus Host Disease Prophylaxis in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies, a Prospective Randomized Controlled Trial
This study aims to evaluate the clinical efficacy of cyclophosphamide in patients receiving a bone marrow graft from a matched unrelated donor in overall survival, progression free survival and cumulative incidence of acute and chronic GvHD. Thirty patients will receive cyclophosphamide while twenty patients will receive antihuman T-lymphocyte immune globulin (ATG).
Status | Recruiting |
Enrollment | 50 |
Est. completion date | November 1, 2026 |
Est. primary completion date | November 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 75 Years |
Eligibility |
Inclusion Criteria: - Men and Women of Any Age - Indication for an HSCT without matched sibling donor - Have a matched unrelated donor (HLA 10 x 10 or 9 x 10) - Hematological malignancy Exclusion Criteria: - Acute leukemias not in complete response (that is > 5% blast in the bone marrow) - Chemorefractory lymphoproliferative disease - Active uncontrolled infection - HCT-CI > 3 - Severe organic disfunction (heart ejection fraction < 45%, glomerular filtration rate < 50 mL.hour, pulmonary DLCO < 50%) - Previous allogeneic bone marrow transplantation - Contraindication to cyclophosphamide or ATG |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospita Israelita Albert Eintein | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
Hospital Israelita Albert Einstein |
Brazil,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Graft Failure Incidence | ANC < 500/microL after 42 days after graft infusion | 2 years | |
Other | Time Until Neutrophil Engraftment | Time to ANC > 500/microL for three consecutive days | 2 years | |
Other | Time Until Platelet Engraftment | Time to platelet count > 50,000/microL, without transfusion in the last 7 days | 2 years | |
Other | Immunological Reconstitution | Total lymphocyte count as well as its subsets (CD4, CD8, CD19, CD56) | Days +60, +100 and +180 | |
Other | Days hospitalized | Days admitted to the hospital | First 100 days after graft infusion | |
Primary | Overall Survival | Time to last follow-up or death | 4 years | |
Secondary | Progression free survival | Time until last follow-up, death or disease relapse | 4 years | |
Secondary | Acute Graft Versus Host Disease | Time until acute GvHD development | 4 years | |
Secondary | Chronic Graft Versus Host Disease | Time until chronic GvHD development | 4 years | |
Secondary | Treatment Related Mortality | Time until death related to HSCT complications | 4 years |
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