RecruitingNCT03802773

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

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


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

10 participants

Start Date

Mar 14, 2019

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

  • 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 Criteria2

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

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Interventions

PROCEDURECB transplantation

Myeloablative conditioning with post-transplant cyclophosphamide in patients receiving a matched CB transplant for hematological malignancies.


Locations(1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, Italy

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