Cord blood boost: new technique shows promise for tough leukemia cases
NCT ID NCT04103879
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new way to prepare cord blood for transplant in 30 people with high-risk leukemia or myelodysplasia. The cord blood was treated with a molecule called UM171 to help it grow more stem cells. The goal was to see if this approach is safe and helps patients recover faster with fewer complications. Early results suggest it may improve survival and reduce side effects like graft-versus-host disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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30 people
The number who actually took part.
- Started
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Nov 2020
- Finished
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Feb 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. High and very high-risk hematologic malignancy defined as: 1. Acute Myeloid Leukemia (Primary induction failure, Chemorefractory relapse, Relapse after allogeneic or autologous transplant, High risk AML in CR1, ≥ CR2) 2. Acute Lymphoid leukemia (Primary induction failure, High risk ALL in CR1, ≥ CR2, Chemorefractory relapse, Relapse after allogeneic or autologous transplant) 3. 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). 4. Chronic myelogenous leukemia (Patients who progressed to blast crisis) 2. 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 3. Karnofsky ≥70. 4. LVE fraction ≥ 40% or fractional shortening \>22% 5. FVC, FEV1 and DLCOc ≥ 50% of predicted 6. Bilirubin \< 2 x ULN; AST and ALT ≤ 2.5 x ULN; alkaline phosphatase ≤ 5 x ULN. 7. Creatinine \< 2.0 mg/dl. 8. HCT-CI ≤3 if patients have ≥5% blasts in the bone marrow and HCT-CI ≤5 if 60-65 years old. Exclusion Criteria: 1. Allogeneic myeloablative transplant within 6 months. 2. Autologous hematopoietic stem cell transplant within 6 months. 3. Active or recent invasive fungal infection. 4. 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. 5. HIV positivity. 6. Hepatitis B or C infection with measurable viral load. 7. Liver cirrhosis. 8. Pregnancy, breastfeeding or unwillingness to use appropriate contraception. 9. Any abnormal condition or laboratory result that is considered by the principal investigator capable of altering patient condition or study outcome. 10. Active central nervous system involvement. 11. Chloroma \> 2 cm.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Erasmus Medical Center
Rotterdam, Gelderland, 3015, Netherlands
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Fred Hutchinson / University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
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University of Colorado School of Medicine. Anschutz Medical Campus
Aurora, Colorado, 80045, United States
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