Cord Blood Transplant With OTS for the Treatment of HIV Positive Hematologic Cancers
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Megakaryoblastic Leukemia
- Acute Erythroid Leukemia
- Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia
- Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Hematopoietic and Lymphoid Cell Neoplasm
- HIV Infection
- Myelodysplastic Syndrome
- Myelodysplastic Syndrome With Excess Blasts
- Non Hodgkin Lymphoma
- Refractory Anemia
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 665 years
- Gender
- Both males and females
Description
OUTLINE: Patients are assigned to 1 of 2 regimens. REGIMEN A: Patients receive fludarabine intravenously (IV) over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 to -6, and undergo total body irradiation (TBI) twice daily (BID) on days -4 to -1. Patients then undergo umbilical cord bloo...
OUTLINE: Patients are assigned to 1 of 2 regimens. REGIMEN A: Patients receive fludarabine intravenously (IV) over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 to -6, and undergo total body irradiation (TBI) twice daily (BID) on days -4 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive umbilical cord blood-derived hematopoietic CD34-positive progenitor cells IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. REGIMEN B: Patients receive fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 4 hours on days -5 to -4, and undergo TBI once daily (QD) on days -2 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive umbilical cord blood-derived hematopoietic CD34-positive progenitor cells IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 28, 80, and 180 days, and then at 1 and 2 years.
Tracking Information
- NCT #
- NCT04083170
- Collaborators
- National Cancer Institute (NCI)
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Principal Investigator: Filippo Milano Fred Hutch/University of Washington Cancer Consortium