Cord Blood Transplantation With Myeloablative Conditioning and Post-transplant Cyclophosphamide (COmPACt Study)

Recruiting now

Conditions studied: Cord Blood Transplantation, Hematological Malignancies

In brief

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.

Key facts

Study ID

NCT03802773

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

10

Starts

2019-03-14

Expected to finish

2025-12-31

Last updated by the study team

2025-04-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Positive serologic markers for human immunodeficiency virus (HIV)
• Acute hepatitis B virus (HBV) or acute hepatitis C virus (HCV) infection

Where it is running

• Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma, RM, Italy (enrolling)

Full record on ClinicalTrials.gov

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