Clinical trial · Interventional
Expanded Access of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies
An Open Label Expanded Access Study of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies
NCT04260698CI-TRIAL-00115372completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Omidubicel is an investigational therapy for patients with high-risk hematologic malignancies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| omidubicel | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- omidubicel
- description
- Received omidubicel
- interventionNames
- Biological: omidubicel
Primary outcomes (2)
- measure
- Time From Transplant to Neutrophil Engraftment
- timeFrame
- by day 42 post-transplant inclusive
- description
- Neutrophil engraftment was defined as achieving an absolute neutrophil count (ANC) greater than or equal to 0.5 x 10\^9/L on 3 consecutive measurements by Day 42 post-transplant inclusive. The first day of the three measurements was designated the day of neutrophil engraftment.
- measure
- Cumulative Incidence of Neutrophil Engraftment
- timeFrame
- by day 42 post-transplant inclusive
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.