Cord Blood Transplantation With Myeloablative Conditioning and Post-transplant Cyclophosphamide (COmPACt Study) (COmPACt)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03802773
Recruitment Status : Unknown
Verified April 2020 by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruitment status was: Recruiting
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 Epstein-Barr virus reactivation, post-transplant lymphoproliferative diseases, overall accounting for increased transplant-related mortality and/or increased relapse incidence. All these findings support the use of alternative approaches for in vivo T cell depletion in the setting of CB transplantation.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with no matched (<7/8 HLA loci) sibling or unrelated donor, candidate to receive a transplant of a matched CB unit (TNC> 2,0 x10^7/kg and > 4/6 loci HLA)
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.
Positive serologic markers for human immunodeficiency virus (HIV)
Acute hepatitis B virus (HBV) or acute hepatitis C virus (HCV) infection