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NCT Number: NCT03802773

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

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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Key information

Conditions

Cord Blood Transplantation Hematologic Diseases Hematologic Neoplasms Hematological Malignancies Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00168, Italy

Location status: Recruiting

Location contact

Andrea Bacigalupo, Prof.

CONTACT

[email protected]

0630154180

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CB transplantation

Procedure

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

Other names: Myeloablative conditioning and post-transplant cyclophosphamide

Primary outcomes

  1. hematopoietic reconstitution

    Time frame: 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

  1. immune reconstitution

    Time frame: day 100 from transplant

    number of CD4+cells at day 100

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Bacigalupo, Prof.

CONTACT

[email protected]

0630154180

Patrizia Chiusolo, MD

CONTACT

[email protected]

0630156244

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: COmPACt

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jan 14, 2019
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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