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

Hematological Malignancies Clinical Trial

— COmPACt  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03802773
• Other study ID #: 2382
• Status: Recruiting
• Start date: March 14, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2022
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Andrea Bacigalupo, Prof.
• Phone: 0630154180
• Email: andrea.bacigalupo[@]unicatt.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2023
• Est. primary completion date: January 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cord Blood Transplantation
• Hematologic Neoplasms
• Hematological Malignancies
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	immune reconstitution	number of CD4+cells at day 100	day 100 from transplant