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New treatment option for Acute Leukemia, High Risk
Official title A Study Testing an Improved Dose of UM171 to Help Make Cord Blood Transplants More Effective and Safe.
ClinicalTrials.gov ID: NCT07301866
What this study is testing
What is ECT-001-CB?
ECT-001-CB is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute leukemia, high risk.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 67
You may be able to join if
- people ≥ 18 and ≤ 67 years old,
- Patient with either i. High risk acute leukemia or myelodysplasia defined as expected 2 year OS or PFS \< 40% after a conventional allogeneic HSC...
- Availability of an adequate CB for expansion: i. ≥ 5/8 HLA match when A, B, C and DRB1 are performed at the allele level. ii. Minimal cell dose: TNC...
- Patients with adequate physical function as measured by: i. Karnofsky score ≥ 70% ii. Hematopoietic comorbidity index (HCT-CI): 0-3 for 2nd...
- A back up graft must have been identified prior to initiation of conditioning regimen.
You likely can't join if
- Allogeneic or autologous myeloablative transplant within last 6 months.
- Patients with inadequate physical function as measured by: i. Active, uncontrolled bacterial, viral or fungal infection (currently taking medication...
- Positive anti-donor HLA antibodies with MFI above 1500 against the selected CB (PI may approve an MFI up to 5000; if above 2500, desensitization is...
- Use of an investigational agent within 30 days (defined as a drug not approved by Health Canada or FDA regardless of indication) of start of...
- Presence of ≥30% blasts in bone marrow or ≥ 0.5 x109/L blasts in circulating blood
- Active central nervous system involvement or chloroma \> 2 cm.
See the full eligibility criteria
- people ≥ 18 and ≤ 67 years old,
- Patient with either i. High risk acute leukemia or myelodysplasia defined as expected 2 year OS or PFS \< 40% after a conventional allogeneic HSC transplant or ii. A hematologic malignancy requiring an allogeneic...
- Availability of an adequate CB for expansion: i. ≥ 5/8 HLA match when A, B, C and DRB1 are performed at the allele level. ii. Minimal cell dose: TNC ≥ 1.5 x 107/kg, and CD34 ≥ 0.5 x 105/kg. iii. Needs to be...
- Patients with adequate physical function as measured by: i. Karnofsky score ≥ 70% ii. Hematopoietic comorbidity index (HCT-CI): 0-3 for 2nd transplant and age 60-65 years, 0-5 if \<60 years old, and 0-2 if 66-67 years...
- A back up graft must have been identified prior to initiation of conditioning regimen.
- Signed written informed consent.
- Female patients of childbearing potential must have a negative serum pregnancy test within 30 days of enrolment and within 30 days of starting of preparative regimen; patient must be willing to use an effective...
- Allogeneic or autologous myeloablative transplant within last 6 months.
- Patients with inadequate physical function as measured by: i. Active, uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of either progression of clinical symptoms or radiologic...
- Positive anti-donor HLA antibodies with MFI above 1500 against the selected CB (PI may approve an MFI up to 5000; if above 2500, desensitization is strongly recommended)
- Use of an investigational agent within 30 days (defined as a drug not approved by Health Canada or FDA regardless of indication) of start of chemotherapy unless documented approval obtained from Sponsor.
- Presence of ≥30% blasts in bone marrow or ≥ 0.5 x109/L blasts in circulating blood
- Active central nervous system involvement or chloroma \> 2 cm.
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 67 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.