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

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ClinicalTrials.gov Identifier: NCT04260698
Recruitment Status : Recruiting
First Posted : February 7, 2020
Last Update Posted : June 10, 2022
Sponsor:
Information provided by (Responsible Party):
Gamida Cell ltd

Study Description
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Brief Summary:
Omidubicel is an investigational therapy for patients with high-risk hematologic malignancies.

Condition or disease Intervention/treatment Phase
Hematological Malignancies Biological: omidubicel Phase 3

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Expanded Access Study of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies
Actual Study Start Date : July 8, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: omidubicel

Omidubicel is a cryopreserved stem/progenitor cell based product comprised of:

  1. Ex vivo expanded, umbilical cord blood-derived hematopoietic CD34+ progenitor cells (cultured fraction (CF))
  2. the non-cultured cell fraction of the same Cord Blood Unit (CBU) (Non-cultured Fraction (NF)) consisting of mature myeloid and lymphoid cells.

Both fractions, i.e. CF and NF, will be kept frozen until they are thawed and infused on the day of transplantation.

 Biological: omidubicel
hematopoietic stem cell transplant
Other Name: NiCord


Outcome Measures
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Primary Outcome Measures :
  1. To assess the time from transplant to neutrophil engraftment [ Time Frame: by day 42 post-transplant inclusive ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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): NCT04260698


Contacts
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Contact: Kelly Myers +97226595631 kelly@gamida-cell.com

Locations
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United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Gary Schiller, MD       GSchiller@mednet.ucla.edu   
Principal Investigator: Gary Schiller, MD         
Stanford University Cancer Institute Recruiting
Palo Alto, California, United States, 94063
Contact: Andrew Rezvani,, MD    650-498-6000      
United States, Illinois
Loyola University, Cardinal Bernardin Cancer Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Stephanie Tsai, MD    708-327-3216      
Principal Investigator: Stephanie Tsai, MD         
United States, Minnesota
University of Minnesota Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: John Wagner, MD    612-625-3918      
Principal Investigator: John Wagner, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Mitchell Horwitz, MD    919-668-1045    mitchell.horwitz@duke.edu   
Principal Investigator: Mitchell Horwitz, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Richard Maziarz, MD    503-494-4606    maziarzr@ohsu.edu   
Principal Investigator: Richard Maziarz, MD         
Sponsors and Collaborators
Gamida Cell ltd
Investigators
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Principal Investigator: Mitchell Horwitz, MD Duke University
More Information
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Responsible Party: Gamida Cell ltd
ClinicalTrials.gov Identifier: NCT04260698    
Other Study ID Numbers: GC P#07.01.020
First Posted: February 7, 2020    Key Record Dates
Last Update Posted: June 10, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases