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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03802773
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : May 5, 2020
Information provided by (Responsible Party):
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Condition or disease Intervention/treatment
Cord Blood Transplantation Hematological Malignancies Procedure: CB transplantation

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cord Blood Transplantation With Myeloablative Conditioning and Post-transplant Cyclophosphamide in Patients With Hematological Malignancies (The COmPACt Study)
Actual Study Start Date : March 14, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine

Intervention Details:
  • Procedure: CB transplantation
    Myeloablative conditioning with post-transplant cyclophosphamide in patients receiving a matched CB transplant for hematological malignancies.
    Other Name: Myeloablative conditioning and post-transplant cyclophosphamide

Primary Outcome Measures :
  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 Outcome Measures :
  1. immune reconstitution [ Time Frame: day 100 from transplant ]
    number of CD4+cells at day 100

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03802773

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Contact: Andrea Bacigalupo, Prof. 0630154180
Contact: Luciana Teofili, MD 0630154373

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Fondazione Policlinico Universitario A. Gemelli IRCCS Recruiting
Roma, RM, Italy, 00168
Contact: Andrea Bacigalupo, Prof.    0630154180   
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Principal Investigator: Patrizia Chiusolo, MD Fondazione Policlinico Universitario A Gemelli IRCCS
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Responsible Party: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Identifier: NCT03802773    
Other Study ID Numbers: 11/2018
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists