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

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03802773
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Anticipated Duration (Months): 24.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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	Phase
Cord Blood Transplantation; Hematological Malignancies	Procedure: CB transplantation

Study Design

• Study Type: Observational
• Anticipated 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: Mar 14, 2019
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Mar 30, 2021

Outcome Measures

Primary Outcome Measures

1. hematopoietic reconstitution [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 [day 100 from transplant]

   number of CD4+cells at day 100

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Policlinico Universitario A. Gemelli IRCCS	Roma	RM	Italy	00168

Sponsors and Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

• Principal Investigator: Patrizia Chiusolo, MD, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• ClinicalTrials.gov Identifier: NCT03802773
• Other Study ID Numbers: 11/2018
• First Posted: Jan 14, 2019
• Last Update Posted: May 5, 2020
• Last Verified: Apr 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms; Hematologic Neoplasms; Cyclophosphamide

Study Results

No Results Posted as of May 5, 2020