Infusion of Off-the-Shelf Ex Vivo Expanded Cryopreserved Cord Blood Progenitor Cells to Augment Single or Double Myeloablative Cord Blood Transplantation in Patients With Hematologic Malignancies.
Phase of Trial: Phase II
Latest Information Update: 16 Jul 2018
At a glance
- Drugs Dilanubicel (Primary) ; Ciclosporin; Cyclophosphamide; Fludarabine; Mycophenolate mofetil; Mycophenolate mofetil
- Indications Acute myeloid leukaemia; Chronic myeloid leukaemia; Graft-versus-host disease; Myelodysplastic syndromes; Precursor cell lymphoblastic leukaemia-lymphoma
- Focus Adverse reactions; Biomarker; Therapeutic Use
- 16 Jul 2018 According to a Nohla Therapeutics media release, the U.S. Food and Drug Administration (FDA) has granted dilanubicel (NLA101), Orphan Drug Designation for reduction of morbidity and mortality associated with hematopoietic stem cell transplant (HSCT). This designation was supported by the results of this study.
- 15 Jun 2018 Results (5 years) presented in a Nohla Therapeutics media release.
- 15 Jun 2018 According to a Nohla Therapeutics media release, long-term follow-up data from this study were presented at the 23rd Congress of European Hematology Association Annual Conference.