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

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ClinicalTrials.gov Identifier: NCT03802773
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Luciana Teofili, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Description
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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

Study Design
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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


Groups and Cohorts
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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

Outcome Measures
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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


Eligibility Criteria
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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)
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03802773


Contacts
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Contact: Andrea Bacigalupo, Prof. 0630154180 andrea.bacigalupo@unicatt.it
Contact: Luciana Teofili, MD 0630154373 luciana.teofili@unicatt.it

Locations
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Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS Recruiting
Roma, RM, Italy, 00168
Contact: Andrea Bacigalupo, Prof.    0630154180    andrea.bacigalupo@unicatt.it   
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
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Principal Investigator: Luciana Teofili, MD Fondazione Policlinico Universitario A Gemelli IRCCS
More Information
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Responsible Party: Luciana Teofili, Medical Director of the UNICATT Cord Blood Bank, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT03802773     History of Changes
Other Study ID Numbers: 11/2018
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019

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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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Neoplasms
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
 Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists