Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Acute Lymphoblastic Leukemia
  • Acute Erythroid Leukemia
  • Acute Megakaryoblastic 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