Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Biphenotypic Leukemia
- Acute Lymphoblastic Leukemia
- Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Hematopoietic and Lymphoid Cell Neoplasm
- Myelodysplastic Syndrome
- Myelodysplastic Syndrome With Excess Blasts
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
OUTLINE: Patients receive either regimen A or regimen B. REGIMEN A: Patients (18 through 45 years old) receive fludarabine intravenously (IV) over 30 minutes on days -8 to -6 and cyclophosphamide IV on days -7 and -6. Patients undergo total body irradiation (TBI) twice daily (BID) on days -4 to -1. ...
OUTLINE: Patients receive either regimen A or regimen B. REGIMEN A: Patients (18 through 45 years old) receive fludarabine intravenously (IV) over 30 minutes on days -8 to -6 and cyclophosphamide IV on days -7 and -6. Patients undergo total body irradiation (TBI) twice daily (BID) on days -4 to -1. Patients receive unmanipulated cord blood unit IV followed by NLA101 IV within the next 24 hours on day 0. REGIMEN B: Patients (18 through 65 years old) receive fludarabine IV over 30-60 minutes on days -6 to -3 and IV over 30 minutes on day -2, cyclophosphamide IV on day -6, and thiotepa IV over 2-4 hours on days -5 and -4. Patients receive unmanipulated cord blood unit IV followed by NLA101 IV within the next 24 hours on day 0. After completion of study treatment, patients are followed up at 180 days, 1 year, and 2 years.
Tracking Information
- NCT #
- NCT03399773
- Collaborators
- Nohla Therapeutics, Inc.
- National Cancer Institute (NCI)
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Principal Investigator: Filippo Milano Fred Hutch/University of Washington Cancer Consortium
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