NCT02730299

Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

ACTIVE_NOT_RECRUITING

NCT ID:

NCT02730299

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

A Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord®, Ex Vivo Expanded, UCB-derived, Stem and Progenitor Cells, vs. Unmanipulated UCB for Patients With Hematological Malignancies

Summary

This study is an open-label, controlled, multicenter, international, Phase III, randomized study of transplantation of NiCord® versus transplantation of one or two unmanipulated, unrelated cord blood units in patients with acute lymphoblastic leukemia or acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia or lymphoma, all with required disease features rendering them eligible for allogeneic transplantation.

Eligibility

Inclusion Criteria:

* Applicable disease criteria
* Patients must have one or two partially HLA-matched CBUs
* Back-up stem cell source
* Adequate Karnofsky/Lansky Performance score
* Sufficient physiological reserves
* Signed written informed consent

Exclusion Criteria:

* HLA-matched donor able to donate
* Prior allogeneic HSCT
* Other active malignancy
* Active or uncontrolled infection
* Active/symptoms of central nervous system (CNS) disease
* Pregnancy or lactation

Disease(s) and\or Condition(s)

Hematological Malignancies

Acute Lymphoblastic Leukemia (ALL)

Acute Myelogenous Leukemia (AML)

Chronic Myelogenous Leukemia (CML)

Myelodysplastic Syndrome (MDS)

Lymphoma

Acute Leukemia

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: NiCord® (omidubicel)
- Description:
- Arm Group Labels: NiCord® (omidubicel)
- Type: OTHER
- Name: Cord Blood Unit
- Description: Cord blood unit
- Arm Group Labels: Unmanipulated CBU(s)

Sponsor

Gamida Cell ltd