Status:
RECRUITING
Cord Blood Transplantation With Myeloablative Conditioning and Post-transplant Cyclophosphamide (COmPACt Study)
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Cord Blood Transplantation
Hematological Malignancies
Eligibility:
All Genders
18-75 years
Brief Summary
Despite anti-thymocyte globulin has a mainstay role in preventing GvHD (and non-relapse mortality) in CB transplantation, it also induces delayed immune recovery, increased risk of cytomegalovirus and...
Detailed Description
Study objectives. The primary objective is to evaluate neutrophil and platelet engraftment and day +100 CD4+ cell count in patients receiving matched CB unit transplant with a myeloablative conditioni...
Eligibility Criteria
Inclusion
- Age: ≥ 18 ≤ 75 years old
- CB unit transplantation (TNC\> 2,0 x10\^7/kg and \> 4/6 loci HLA matched)
- Myeloablative conditioning regimen consisting of either Thiotepa/ Busulfan/ Fludarabine or TBI/ Fludarabine
- GVHD prophylaxis including PT-Cy (30 mg/kg or more on days + 3and +5) CSA and MMF
- Diagnosis of 1 of the following hematological malignancies: Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome, high risk Acute Lymphoblastic Leukemia (ALL), Bi phenotypic/undifferentiated leukemia, Chronic Myeloid Leukemia resistant to TK inhibitors, Ph-neg Myeloproliferative Neoplasms, resistant/relapsing Non-Hodgkin's lymphoma ineligible for an autologous transplant.
Exclusion
- Positive serologic markers for human immunodeficiency virus (HIV)
- Acute hepatitis B virus (HBV) or acute hepatitis C virus (HCV) infection
Key Trial Info
Start Date :
March 14 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03802773
Start Date
March 14 2019
End Date
December 31 2025
Last Update
April 9 2025
Active Locations (1)
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1
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, RM, Italy, 00168