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

Primary Purpose

Hematological Malignancies

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
omidubicel
Sponsored by
Gamida Cell ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematological Malignancies

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA
  • Stanford University Cancer Institute
  • Loyola University, Cardinal Bernardin Cancer Center
  • University of Minnesota Masonic Cancer Center
  • Duke University Medical Center
  • Oregon Health & Science University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

omidubicel

Arm Description

Omidubicel is a cryopreserved stem/progenitor cell based product comprised of: Ex vivo expanded, umbilical cord blood-derived hematopoietic CD34+ progenitor cells (cultured fraction (CF)) 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.

Outcomes

Primary Outcome Measures

To assess the time from transplant to neutrophil engraftment

Secondary Outcome Measures

Full Information

First Posted
February 5, 2020
Last Updated
July 27, 2023
Sponsor
Gamida Cell ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04260698
Brief Title
Expanded Access of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies
Official Title
An Open Label Expanded Access Study of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 8, 2020 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gamida Cell ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Malignancies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
omidubicel
Arm Type
Experimental
Arm Description
Omidubicel is a cryopreserved stem/progenitor cell based product comprised of: Ex vivo expanded, umbilical cord blood-derived hematopoietic CD34+ progenitor cells (cultured fraction (CF)) 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.
Intervention Type
Biological
Intervention Name(s)
omidubicel
Other Intervention Name(s)
NiCord
Intervention Description
hematopoietic stem cell transplant
Primary Outcome Measure Information:
Title
To assess the time from transplant to neutrophil engraftment
Time Frame
by day 42 post-transplant inclusive

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Horwitz, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford University Cancer Institute
City
Palo Alto
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Loyola University, Cardinal Bernardin Cancer Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Minnesota Masonic Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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