Spots Global Cancer Trial Database for Comparison of PT-Cy at a Dose of 25 mg/kg/Day and PT-Cy at a Dose of 50 mg/kg/Day in GVHD Prophylaxis
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Trial Identification
Brief Title: Comparison of PT-Cy at a Dose of 25 mg/kg/Day and PT-Cy at a Dose of 50 mg/kg/Day in GVHD Prophylaxis
Official Title: A Randomized, Open-label, Single-center Study Comparing Cyclophosphamide at a Dose of 25 mg/kg/Day and Cyclophosphamide at a Dose of 50 mg/kg/Day in Graft Versus Host Disease Prophylaxis
Study ID: NCT05158608
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: Elena Parovichnikova, MD, D.Sc
Affiliation: National Research Center for Hematology
Role: PRINCIPAL_INVESTIGATOR
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