Status:
ACTIVE_NOT_RECRUITING
US Study of UM171-Expanded CB in Patients With High Risk Leukemia/Myelodysplasia
Lead Sponsor:
ExCellThera inc.
Collaborating Sponsors:
Fred Hutchinson Cancer Center
Conditions:
High Risk Hematological Malignancy
Cord Blood Transplant
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Cord blood (CB) transplants are an option for patients lacking an HLA identical donor but are hampered by low cell dose, prolonged aplasia and high transplant related mortality. UM171, a novel and pot...
Eligibility Criteria
Inclusion
- High and very high-risk hematologic malignancy defined as:
- Acute Myeloid Leukemia (Primary induction failure, Chemorefractory relapse, Relapse after allogeneic or autologous transplant, High risk AML in CR1, ≥ CR2)
- Acute Lymphoid leukemia (Primary induction failure, High risk ALL in CR1, ≥ CR2, Chemorefractory relapse, Relapse after allogeneic or autologous transplant)
- Myelodysplastic syndrome (Relapse after allogeneic or autologous transplant, ≥10% blasts within 30 days of start of conditioning regimen, Poor and very poor cytogenetics abnormalities, CMML with HCT-specific CPSS score high or intermediate-2, Stable disease, Progressive disease while on azacitidine).
- Chronic myelogenous leukemia (Patients who progressed to blast crisis)
- Availability of 2 CBs ≥ 4/6 HLA match with pre-freeze CD34+ cell count ≥0.5 x 10E5/kg and TNC≥1.5 x 10E7/kg
- Karnofsky ≥70.
- LVE fraction ≥ 40% or fractional shortening \>22%
- FVC, FEV1 and DLCOc ≥ 50% of predicted
- Bilirubin \< 2 x ULN; AST and ALT ≤ 2.5 x ULN; alkaline phosphatase ≤ 5 x ULN.
- Creatinine \< 2.0 mg/dl.
- HCT-CI ≤3 if patients have ≥5% blasts in the bone marrow and HCT-CI ≤5 if 60-65 years old.
Exclusion
- Allogeneic myeloablative transplant within 6 months.
- Autologous hematopoietic stem cell transplant within 6 months.
- Active or recent invasive fungal infection.
- Presence of a malignancy other than the one for which the UCB transplant is being performed and the expected survival related to the malignancy is estimated to be less than 75% at 5 years.
- HIV positivity.
- Hepatitis B or C infection with measurable viral load.
- Liver cirrhosis.
- Pregnancy, breastfeeding or unwillingness to use appropriate contraception.
- Any abnormal condition or laboratory result that is considered by the principal investigator capable of altering patient condition or study outcome.
- Active central nervous system involvement.
- Chloroma \> 2 cm.
Key Trial Info
Start Date :
November 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04103879
Start Date
November 13 2020
End Date
February 1 2026
Last Update
February 25 2025
Active Locations (3)
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1
University of Colorado School of Medicine. Anschutz Medical Campus
Aurora, Colorado, United States, 80045
2
Fred Hutchinson / University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
3
Erasmus Medical Center
Rotterdam, Gelderland, Netherlands, 3015