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Hematopoietic Stem Cell Transplant

Expanded Cord Blood Transplant for Blood Cancers

Phase 2
Waitlist Available
Research Sponsored by ExCellThera inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Chronic myelogenous leukemia (Patients who progressed to blast crisis)
Acute Lymphoid leukemia (Primary induction failure, High risk ALL in CR1, ≥ CR2, Chemorefractory relapse, Relapse after allogeneic or autologous transplant)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years post-transplant
Awards & highlights

Study Summary

This trial is testing a method to expand cord blood cells so that they can be used in transplants for patients with high risk acute leukemia or myelodysplasia. The method has been shown to be safe and effective in a previous trial, and this trial is testing it in a group of patients with a higher risk of the disease.

Who is the study for?
This trial is for patients with high-risk leukemia or myelodysplasia, including those who have failed previous treatments or have advanced disease stages. Participants must be in relatively good physical condition with adequate organ function and not pregnant. They should not have had certain recent transplants, active infections, HIV, other malignancies with poor prognosis, or liver cirrhosis.Check my eligibility
What is being tested?
The study tests ECT-001-CB (UM171-Expanded Cord Blood Transplant) in patients with high-risk blood cancers. It aims to improve outcomes of cord blood transplants by using a molecule that helps stem cells renew themselves. This could lead to faster recovery post-transplant and better survival rates.See study design
What are the potential side effects?
Previous trials showed low risk of transplant-related mortality (5%) and severe acute graft-versus-host disease (10%). There was no moderate-severe chronic GVHD observed. Side effects may include immune system reactions and complications related to bone marrow transplantation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My leukemia has progressed to a more severe stage.
Select...
My leukemia has not responded well to initial treatments or has come back after a transplant.
Select...
My blood cancer is considered high risk, including AML with specific complications.
Select...
I have two cord blood units that match at least 4 out of 6 HLA markers and meet the required cell counts.
Select...
I am able to care for myself but may not be able to do active work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years post-transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse events of ECT-001-CB
Relapse-free survival
Secondary outcome measures
GRFS and CRFS
Incidence of GVHD
Incidence of grade 3 or higher infectious complications
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: ECT-001-Expanded CBExperimental Treatment1 Intervention
Patients will receive a myeloablative conditioning regimen. The cord to be expanded will undergo CD34+ selection. The CD34- product is cryopreserved and will be thawed and infused on Day +1 post-transplant. The CD34+ product will be placed in a closed culture with UM171 for a 7-day expansion and is infused on Day 0. Patients will receive standard supportive care and GVHD prophylaxis (such as MMF and tacrolimus).

Find a Location

Who is running the clinical trial?

ExCellThera inc.Lead Sponsor
4 Previous Clinical Trials
62 Total Patients Enrolled
2 Trials studying Cord Blood Transplant
42 Patients Enrolled for Cord Blood Transplant
Fred Hutchinson Cancer CenterOTHER
556 Previous Clinical Trials
1,343,238 Total Patients Enrolled

Media Library

ECT-001-CB (UM171-Expanded Cord Blood Transplant) (Hematopoietic Stem Cell Transplant) Clinical Trial Eligibility Overview. Trial Name: NCT04103879 — Phase 2
Cord Blood Transplant Research Study Groups: ECT-001-Expanded CB
Cord Blood Transplant Clinical Trial 2023: ECT-001-CB (UM171-Expanded Cord Blood Transplant) Highlights & Side Effects. Trial Name: NCT04103879 — Phase 2
ECT-001-CB (UM171-Expanded Cord Blood Transplant) (Hematopoietic Stem Cell Transplant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04103879 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study allow people who are over 40 years old to participate?

"This study's eligibility requirements state that all participants must be between 18-65 years old."

Answered by AI

Does the FDA allow ECT-001-CB (UM171-Expanded Cord Blood Transplant) to be used on patients?

"ECT-001-CB (UM171-Expanded Cord Blood Transplant) has not been proven effective yet, but there is some data supporting its safety which earned it a score of 2."

Answered by AI

Can new patients still join this clinical trial?

"The study is still recruiting patients, as of the latest update on clinicaltrials.gov from January 12th, 2022. This information was first posted on November 13th, 2020."

Answered by AI

Who meets the qualifications to take part in this drug trial?

"This trial is looking for 20 patients that have undergone a cord blood transplant and are between the ages of 18 and 65. The following criteria must be met: 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"

Answered by AI

How many patients are enrolled in this trial?

"Yes, as of 1/12/2022 this trial is still recruiting patients. The original posting was on 11/13/2020. 20 people are needed for the study which will take place at a single site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
US Study of UM171-Expanded CB in Patients With High Risk Leukemia/Myelodysplasia
2020. "US Study of UM171-Expanded CB in Patients With High Risk Leukemia/Myelodysplasia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04103879.
~10 spots leftby Feb 2026
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