About this 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Acute leukemias not in complete response (that is > 5% blast in the bone marrow)
Chemorefractory lymphoproliferative disease
Active uncontrolled infection
HCT-CI > 3
Trial design
Parallel
Treatments tested in this trial
Cyclophosphamide
DrugCyclophosphamide 1000 mg/flask
ATG
DrugAntihuman T-Lymphocyte Immune Globulin 25 mg/flask
Treatment groups
Trial outcomes
Primary outcomes
Overall Survival
Time to last follow-up or death
Secondary outcomes
Progression free survival
Time until last follow-up, death or disease relapse
Acute Graft Versus Host Disease
Time until acute GvHD development
Chronic Graft Versus Host Disease
Time until chronic GvHD development
Treatment Related Mortality
Time until death related to HSCT complications
Other outcomes
Graft Failure Incidence
ANC \< 500/microL after 42 days after graft infusion
Time Until Neutrophil Engraftment
Time to ANC \> 500/microL for three consecutive days
Time Until Platelet Engraftment
Time to platelet count \> 50,000/microL, without transfusion in the last 7 days
Immunological Reconstitution
Total lymphocyte count as well as its subsets (CD4, CD8, CD19, CD56)
Sponsors and contacts
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