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NCT04260698 Clinical Trial

Expanded Access of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies

Hematological Malignancies Clinical Trial

Official title:
An Open Label Expanded Access Study of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04260698
Other study ID # GC P#07.01.020
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date July 8, 2020
Est. completion date May 31, 2025

Study information
Verified date July 2023
Source Gamida Cell ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Omidubicel is an investigational therapy for patients with high-risk hematologic malignancies.

Description:

Successful blood and marrow transplantation (BMT) requires the infusion of a sufficient number of hematopoietic stem/progenitor cells (HSPCs), capable of both homing to the bone marrow and regenerating a full array of hematopoietic cell lineages with early and late repopulating ability in a timely fashion. Omidubicel is a stem/progenitor cell-based product composed of ex vivo expanded allogeneic cells from one entire unit of umbilical cord blood. Omidubicel utilizes the small molecule nicotinamide (NAM), as an epigenetic approach to inhibit differentiation and to increase the migration, bone marrow (BM) homing and engraftment efficiency of hematopoietic progenitor cells (HPC) expanded in ex vivo cultures. The overall study objectives are to provide access to omidubicel for transplantation in patients with hematological malignancies and to collect additional safety and efficacy data.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 36
Est. completion date May 31, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - Patients must be at least 12 years of age - Applicable disease criteria - Patients must have one or two partially HLA-matched CBUs - Back-up stem cell source - Sufficient physiological reserves - Females of childbearing potential agree to use appropriate method of contraception - Signed written informed consent Exclusion Criteria: - Extensive bone marrow fibrosis - Donor specific anti-HLA antibodies - Pregnancy - Medically unsuitable for transplant

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• omidubicel
hematopoietic stem cell transplant

Locations
Country Name City State
United States Duke University Medical Center Durham North Carolina
United States UCLA Los Angeles California
United States Loyola University, Cardinal Bernardin Cancer Center Maywood Illinois
United States University of Minnesota Masonic Cancer Center Minneapolis Minnesota
United States Stanford University Cancer Institute Palo Alto California
United States Oregon Health & Science University Portland Oregon

Sponsors (1)
Lead Sponsor Collaborator
Gamida Cell ltd

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To assess the time from transplant to neutrophil engraftment by day 42 post-transplant inclusive
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