IRB #

STUDY00021119

Title

An Open Label Expanded Access Study of Omidubicel, for Allogeneic Transplantation in Patients with Hematological Malignancies

Principal Investigator

Richard Maziarz

Study Purpose

The overall study objectives are to provide access to omidubicel (the study cells) for transplantation in participants with hematological malignancies and to collect additional safety and efficacy data.

Medical Condition(s)

Acute lymphoblastic leukemia (ALL)
Acute myelogenous leukemia (AML)
Chronic myelogenous leukemia (CML)
Chronic lymphocytic leukemia (CLL)
Myelodysplastic Syndrome (MDS)
Biphenotypic/Undifferentiated/Prolymphocytic/Dendritic Cell Leukemias and Natural Killer Cell Malignancies,
Adult T-cell leukemia/lymphoma
Lymphoma

Eligibility Criteria

Participants must be at least 12 years of age

Participants must have a form of cancer potentially treated by an allogeneic stem cell transplant. "allogeneic stem cell transplant" means that the cells come from a healthy donor. Diseases for which an allogeneic transplant may be treated includes ALL, AML, CML, CLL, MDS, Biphenotypic / Undifferentiated/Prolymphocytic/Dendritic Cell Leukemias and Natural Killer Cell Malignancies, Adult T-cell leukemia/lymphoma, or Lymphoma.

Participants must have a partially matched Cord Blood Unit, and another to be used as back-up in case of manufacturing failure

Females of childbearing potential must use an adequate method of birth control

Age Range

12 - 100

Healthy Volunteers Needed

No

Duration of Participation

Total study duration per participant is approximately 780 days

Minors Included

Yes

Contact

Knight Cancer Clinical Trials
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

Gamida

Recruitment End

04/01/2022

Compensation Provided

No


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