Multi-Center, Open-Label Randomized Study of Single or Double Myeloablative Cord Blood Transplantation With or Without Infusion of Off-The-Shelf Ex Vivo Expanded Cryopreserved Cord Blood Progenitor Cells in Patients With Hematologic Malignancies
Status: Active, no longer recruiting
Phase of Trial: Phase II
Latest Information Update: 04 Apr 2019
Price : $35 *
At a glance
- Drugs Dilanubicel (Primary) ; Ciclosporin; Ciclosporin; Cyclophosphamide; Fludarabine; Mycophenolate mofetil; Mycophenolate mofetil; Thiotepa
- Indications Acute biphenotypic leukaemia; Acute myeloid leukaemia; Chronic myeloid leukaemia; Haematological malignancies; Myelodysplastic syndromes; Precursor cell lymphoblastic leukaemia-lymphoma
- Focus Therapeutic Use
- Sponsors Nohla Therapeutics
- 06 Aug 2018 According to a Nohla Therapeutics media release, based on the data from this trial the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to dilanubicel (NLA101) for patients with high-risk hematologic malignancies receiving an allogeneic cord blood transplant.
- 06 Jun 2018 Status changed from recruiting to active, no longer recruiting, according to a Nohla Therapeutics media release.
- 06 Jun 2018 According to a Nohla Therapeutics media release, based on this data, the European Medicines Agency (EMA) has granted dilanubicel (NLA101) a PRIority MEdicines (PRIME) designation for the treatment of patients receiving a Hematopoietic Stem Cell Transplant (HSCT).