About this trial
The goal of this clinical research study is to learn if intermediate-intensity conditioning therapy followed by a cord blood transplant can help to control high-risk hematological malignancies in patients who need a second allogeneic stem cell transplantation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient aged 0-60 y/o at the time of consent. Adult is defined as patients 18 years of age or older at the time of consent.
Patient must have relapsed >100 days since first transplant.
Karnofsky score equal or greater than 70% for patients aged 16 years and older or Lansky score equal or greater than 70% for patients less than 16 years old (See Appendix B; inpatient Leukemia service transfers without discharge are acceptable provided patient has equivalent KPS as if were outpatient).
Calculated creatinine clearance > 50 ml/min.
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
Drugs Cyclophosphamide
DrugGiven as standard of care treatment through IV infusion
Fludarabine
DrugGiven as standard of care treatment through IV infusion
Thiotepa
DrugGiven as standard of care treatment through IV infusion
Tacrolimus
DrugGiven as standard of care treatment through IV infusion
Mycophenolate mofetil
DrugGiven as standard of care treatment through IV infusion
Treatment groups
Trial outcomes
Primary outcomes
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Sponsors and contacts
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