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

NCT03802773 | Recruiting

• 1 other identifier: 2382
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cord Blood Transplantation; Hematological Malignancies

Outcome Measures

Primary Outcomes (1)

• hematopoietic reconstitution

  number of days for neutrophil (\> 0.5x10\^9/L) and platelet (\> 20x10\^9/L) engraftment

  first post-transplant 1 day with neutrophil > 0.5x10^9/L and platelet > 20x10^9/L

Secondary Outcomes (1)

• immune reconstitution

  day 100 from transplant

Interventions

CB transplantation PROCEDURE

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

Also known as: Myeloablative conditioning and post-transplant cyclophosphamide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with no matched (\<7/8 HLA loci) sibling or unrelated donor, candidate to receive a transplant of a matched CB unit (TNC\> 2,0 x10\^7/kg and \> 4/6 loci HLA)

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Bone Marrow Purging

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Blood Component Removal; Therapeutics

Study Officials

• Patrizia Chiusolo, MD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Bacigalupo, Prof.

CONTACT

0630154180; andrea.bacigalupo@unicatt.it

Patrizia Chiusolo, MD

CONTACT

0630156244; patrizia.chiusolo@unicatt.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 14, 2019
• Study Start: March 14, 2019
• Primary Completion: November 26, 2025
• Study Completion: December 31, 2025
• Last Updated: April 9, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)