NCT04260698

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

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

ACTIVE_NOT_RECRUITING

NCT ID:

NCT04260698

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

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

Summary

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

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

Disease(s) and\or Condition(s)

Hematological Malignancies

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: BIOLOGICAL
- Name: omidubicel
- Description: hematopoietic stem cell transplant
- Arm Group Labels: omidubicel

Sponsor

Gamida Cell ltd