Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT03802773

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

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-04-09

10

Participants Needed

1

Research Sites

354 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years old
  • Receiving a cord blood unit transplant with total nucleated cells greater than 2.0 x10^7/kg and at least 4/6 HLA loci matched
  • Undergoing a myeloablative conditioning regimen with either Thiotepa/Busulfan/Fludarabine or total body irradiation with Fludarabine
  • Receiving graft-versus-host disease prophylaxis including post-transplant cyclophosphamide (30 mg/kg or more on days +3 and +5), cyclosporine, and mycophenolate mofetil
  • Diagnosed with one of these hematological malignancies: Acute Myeloid Leukemia, Myelodysplastic Syndrome, high risk Acute Lymphoblastic Leukemia, Bi phenotypic or undifferentiated leukemia, Chronic Myeloid Leukemia resistant to TK inhibitors, Ph-negative Myeloproliferative Neoplasms, or resistant/relapsing Non-Hodgkin's lymphoma ineligible for autologous transplant
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, Italy, 00168

Actively Recruiting

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Research Team

A

Andrea Bacigalupo, Prof.

CONTACT

P

Patrizia Chiusolo, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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