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
Who is this study for? Patients with Graft versus Host Disease, Infection Viral, Engraft Failure
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Brazil
Hospita Israelita Albert Eintein
RECRUITING
São Paulo
Contact Information
Primary
Andreza A Feitosa Ribeiro
andreza.ribeiro@einstein.br
+5511992512523
Time Frame
Start Date: 2018-11-06
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 50
Treatments
Experimental: Post Cyclophosphamide
Cyclophosphamide 50 mg/Kg on days +3 and +4 AND Calcineurin Inhibitor from day +5 AND Mycofenolate Mofetil from day +5 until day +35
Active_comparator: Thymoglobulin (ATG)
Thymoglobulin (ATG) total dose 5 mg/Kg from day -4 until day -1 AND Calcineurin Inhibitor from day +5 AND Methotrexate on days +1, +3, +6 and +11
Related Therapeutic Areas
Sponsors
Leads: Hospital Israelita Albert Einstein