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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

Trial Profile

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

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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
  • Most Recent Events

    • 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).
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