Status:
RECRUITING
Post Transplant Cyclophosphamide in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies
Lead Sponsor:
Hospital Israelita Albert Einstein
Conditions:
Bone Marrow Transplant Complications
Graft Versus Host Disease
Eligibility:
All Genders
1-75 years
Phase:
PHASE2
PHASE3
Brief 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 cumula...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03818334
Start Date
November 6 2018
End Date
November 1 2026
Last Update
February 1 2019
Active Locations (1)
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1
Hospita Israelita Albert Eintein
São Paulo, São Paulo, Brazil, 05652-900