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

NCT03802773 — Recruiting, 10 participants, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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Cord Blood Transplantation With Myeloablative Conditioning and Post-transplant Cyclophosphamide in Patients With Hematological Malignancies (The COmPACt Study)

Registry	NCT03802773, acronym COmPACt
Status	Recruiting
Study type	Observational
Enrollment	10 (Estimated)
Sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Conditions	Cord Blood Transplantation, Hematological Malignancies
Interventions	CB transplantation (Procedure)
Dates	start 2019-03-14, primary completion 2025-11-26 (estimated), completion 2025-12-31 (estimated), first posted 2019-01-14, last updated 2025-04-09
Locations	1 site in Italy

-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 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.

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+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 conditioning regimen and a GVHD prophylaxis including post-transplant cyclophosphamide. Secondary objective is to estimate the incidence and severity of acute and chronic GVHD. Study endpoints. Primary endpoints are hematopoietic engraftment and day +100 CD4+ cell count. Secondary endpoints are acute and chronic GVHD

+Arms and interventions

CB transplantation (Procedure), also known as Myeloablative conditioning and post-transplant cyclophosphamide: Myeloablative conditioning with post-transplant cyclophosphamide in patients receiving a matched CB transplant for hematological malignancies.

+Outcome measures

Primary outcomes

hematopoietic reconstitution [first post-transplant 1 day with neutrophil > 0.5x10^9/L and platelet > 20x10^9/L]: number of days for neutrophil (> 0.5x10\^9/L) and platelet (> 20x10\^9/L) engraftment

Secondary outcomes

immune reconstitution [day 100 from transplant]: number of CD4+cells at day 100

+Eligibility

Sex: All, ages: 18 Years to 75 Years

Inclusion Criteria:

* 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 Criteria:

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

+Locations (1)

Facility	City	Country	Status
Fondazione Policlinico Universitario A. Gemelli IRCCS	Roma, RM	Italy	Recruiting

+Investigators

Patrizia Chiusolo, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS