A Phase 1 Trial of a Single ProHema® CB Product for Pediatric Patients With Hematologic Malignancies

Stopped early · Phase 1

Conditions studied: Hematologic Malignancies

In brief

This is an open-label, safety study of a single ProHema-CB product administered following myeloablative conditioning regimen in pediatric subjects with hematologic malignancies.

Key facts

Study ID

NCT02354417

Run by

Fate Therapeutics

People needed

3

Starts

2014-12-01

Expected to finish

2017-02-01

Last updated by the study team

2018-10-10

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects aged 1 to 18 years, inclusive.
• Subjects with hematologic malignancies for whom allogeneic stem cell transplantation is deemed clinically appropriate.
• Acute Myelogenous Leukemia (AML) in high risk 1st or subsequent CR
• Acute Lymphoblastic Leukemia (ALL) in CR
• NK cell lymphoblastic leukemia in any CR
• Biphenotypic or undifferentiated leukemia in 1st or subsequent CR
• Myelodysplastic Syndrome (MDS) at any stage.
• Chronic Myelogenous Leukemia (CML) All subjects with evidence of CNS leukemia must be treated and be in CNS CR to be eligible for trial.
• Lack of 5-6/6 HLA matched related or 8/8 HLA A, B, C, DRß1 matched unrelated donor; or unrelated donor not available within appropriate timeframe, as determined by the transplant physician.
• Availability of suitable primary and secondary umbilical cord blood (UCB) units.
• Adequate performance status, defined as:
• Subjects ≥ 16 years: Karnofsky score ≥ 70%.
• Subjects < 16 years: Lansky score ≥ 70%.
• Cardiac: Left ventricular ejection fraction at rest must be > 40%, or shortening fraction > 26%.
• Pulmonary:
• Subjects > 10 years: DLCO (diffusion capacity) > 50% of predicted (corrected for hemoglobin)
• FEV1, FVC > 50% of predicted; Note: If unable to perform pulmonary tests, then O2 saturation > 92% on room air.
• Renal: Serum creatinine within normal range for age, or if serum creatinine outside normal range for age, then renal function (creatinine clearance or GFR) > 70mL/min/1.73m2.
• Hepatic: Bilirubin ≤ 2.5 mg/dL (except in the case of Gilbert's syndrome or ongoing hemolytic anemia); and ALT, AST and Alkaline Phosphatase ≤ 5 × ULN.
• Signed IRB approved Informed Consent Form (ICF).

You may not qualify if…

• Female subjects that are pregnant or breastfeeding.
• Evidence of HIV infection or HIV positive serology.
• Current uncontrolled bacterial, viral or fungal infection.
• Prior allogeneic hematopoietic stem cell transplant.
• Autologous transplant < 12 months prior to enrollment.
• Prior autologous transplant for the disease for which the UCB transplant is being performed.
• Active malignancy other than the one for which the UCB transplant is being performed within 12 months of enrollment.
• Inability to receive TBI.
• Requirement of supplemental oxygen.
• HLA-matched related donor able to donate.
• Use of an investigational drug within 30 days prior to screening.
• Subject is unlikely to comply with the protocol requirements, instructions and study-related restrictions

Where it is running

• City of Hope — Duarte, California, United States
• Boston Children's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.