Actively Recruiting
A Study Testing an Improved Dose of UM171 to Help Make Cord Blood Transplants More Effective and Safe.
Led by Ciusss de L'Est de l'Île de Montréal · Updated on 2025-12-24
7
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
Sponsors
C
Ciusss de L'Est de l'Île de Montréal
Lead Sponsor
S
Stem Cell Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical study is testing a new way to improve stem cell transplants for adults with high-risk blood cancers, such as leukemia or myelodysplasia, who do not have a suitable donor. The transplant uses stem cells from umbilical cord blood that have been expanded in the lab using a molecule called UM171. Previous studies showed that UM171 helps these cells grow and work better, leading to faster blood count recovery and fewer complications. In this study, researchers are testing whether increasing the dose of UM171 during the lab expansion process can make the transplant less toxic. The hypothesis is that using a higher dose of UM171 to expand cord blood stem cells will help patients recover blood counts faster after transplant by improving the growth and function of the cells. This may lead to better immune recovery, fewer infections, shorter hospital stays, and improved overall outcomes. Only seven patients will be enrolled, and they will be followed for one year after their transplant.
CONDITIONS
Official Title
A Study Testing an Improved Dose of UM171 to Help Make Cord Blood Transplants More Effective and Safe.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 67 years
- Diagnosis of high-risk acute leukemia or myelodysplasia with expected 2-year survival or progression-free survival below 40% after a conventional allogeneic transplant, or another hematologic malignancy needing an allogeneic stem cell transplant without a suitable donor
- Availability of an adequate cord blood unit for expansion with at least a 5/8 HLA allele match and minimum cell doses of TNC 5 1.5 x 10^7/kg and CD34 5 0.5 x 10^5/kg
- Cord blood must be erythrodepleted before cryopreservation and come from an accredited or approved cord bank
- Patient weight at cord selection used for eligibility; if weight increases by more than 5% before admission affecting eligibility, approval is needed to proceed
- Adequate physical function with Karnofsky score 5 70%
- Hematopoietic comorbidity index within specified ranges based on age and transplant number
- Adequate cardiac function with left ventricular ejection fraction 5 40% within 60 days before conditioning
- Adequate pulmonary function with FVC, FEV1, and DLCOc 5 50% of predicted within 60 days before conditioning
- Adequate liver function with bilirubin less than 2 times upper limit of normal (ULN), AST and ALT 6 2.5 times ULN (up to 3 times ULN with approval), and alkaline phosphatase 6 5 times ULN
- Adequate kidney function with creatinine clearance 5 60 ml/min/1.73m2
- Backup graft identified before conditioning
- Signed informed consent
- Female patients of childbearing potential must have a negative pregnancy test within 30 days before enrollment and conditioning and agree to use effective contraception during the study
You will not qualify if you...
- Allogeneic or autologous myeloablative transplant within the last 6 months
- Active, uncontrolled bacterial, viral, or fungal infection with worsening symptoms or no response to treatment
- Presence of another malignancy with less than 75% expected 5-year survival
- Positive for HIV
- Hepatitis B or C infection with measurable viral load or liver cirrhosis
- Positive anti-donor HLA antibodies with high mean fluorescence intensity above 1500 against selected cord blood
- Use of investigational drugs within 30 days before starting chemotherapy unless approved
- Bone marrow blasts 30% or higher or circulating blood blasts 5 0.5 x 10^9/L
- Active central nervous system involvement or chloroma larger than 2 cm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
Research Team
S
Sandra Cohen, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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