High Risk Hematologic MalignancyPhase 2NCT03913026

UM171 Expanded Cord Blood In Patients With High-Risk Acute Leukemia/Myelodysplasia

A Phase 2 study testing Transplant with an expanded ECT-001 cord blood in people with High Risk Hematologic Malignancy and Cord Blood Transplant, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: High Risk Hematologic Malignancy, Cord Blood Transplant
What is being tested?: Transplant with an expanded ECT-001 cord blood
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteCanada
Study dates: 1 Apr 2019to Jun 2027
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Presence of high-risk acute leukemia/myelodysplasia defined as one of the following:
Acute Myeloid Leukemia:
Primary induction failure (no CR or CRi after ≥ 2 courses of induction therapy or after ≥ 1 induction containing high dose Ara-C)
Chemorefractory relapse (no CR or CRi after 1 chemointensive treatment)
Relapse after allogeneic or autologous transplant
High risk AML in CR1: i) any adverse genetic abnormality as defined by European Leukemia Net excluding FLT3 mutation; ii) secondary or therapy related AML excluding good risk genetic abnormalities (as defined by ELN); or iii) any other poor risk feature known to be associated with a PFS or DFS ≤40% at 2 years after conventional transplantation.

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CR2 excluding good risk genetic abnormalities defined by ELN
≥CR3
Acute Lymphoid Leukemia
Primary induction failure (≥ 2 inductions)
Chemorefractory relapse (at least 1 intensive induction chemotherapy; blinatumomab, inotuzumab or CAR-T cells may be considered as an equivalent)
Relapse after allogeneic or autologous transplant
High risk ALL in CR1: Ph like ALL or any other poor risk feature known to be associated with an PFS or DFS ≤40% at 2 years after conventional transplantation.
≥CR2
MRD+ within 1 month of start of conditioning regimen.
Myelodysplastic syndrome
Relapse after allogeneic or autologous transplant
≥10 % blasts within 1 month of start of conditioning regimen
Very poor cytogenetics (>3 abnormalities)
Any poor risk feature known to be associated with a PFS or DFS ≤40% at 2 years after conventional transplantation
TP53 mutation
≥40 years old and RAS or JAK2 mutation
CMML with HCT-specific CPSS score high or intermediate-2
Stable disease (absence of CR/PR/HI) after 6 cycles of azacitidine (or another demethylating agent)
Progressive disease while on azacitidine (or another demethylating agent)
18-70 years old
Availability of 2 CBs ≥ 4/8 HLA match when A, B, C and DRB1 are performed at the allele level.
Cord to be expanded:
CD34+ cell count >0.5 x 105/kg and TNC>1.5 x 107/kg (these numbers are all pre-freeze)
Needs to be erythrodepleted by bank prior to cryopreservation
Must come from a cord bank that is FACT (Foundation for the Accreditation of Cellular Therapy) accredited, FDA approved or eligible for NMDP IND.
Non-expanded CB/back-up cord:
Pre-freeze TNC count ≥ 2.0 x 107/kg with CD34+ cells ≥1.5 x 105/kg or TNC count ≥ 1.5 x 107 TNC/kg with CD34+ cells ≥1.7 x 105/kg. If a single cord does not meet these criteria, 2 back up cords will be an acceptable alternative with a minimum for each of 1.5 x 107/kg TNC and 1 x 105/kg CD34+ cells; another acceptable HSC back up source could be a haploidentical donor with medical clearance prior to starting conditioning regimen.
Must come from a cord bank that is FACT accredited, FDA approved or eligible for NMDP IND
Karnofsky score ≥ 70%
Bilirubin < 2 x upper limit of normal (ULN) unless felt to be related to Gilbert's disease or hemolysis; AST and ALT ≤ 2.5 x ULN; alkaline phosphatase ≤ 5 x ULN.
Estimated or measured creatinine clearance ≥ 60 ml/min/1.73m2.
Hematopoietic cell transplantation specific comorbidity index (HCT-CI) ≤5 for patients < 60 years old; HCT-CI ≤3 for patients < 60 years old and acute leukemia not in CR/CRi; HCT-CI ≤3 for patients 60-65 years old; HCT-CI ≤1 if 66-70 years old.
Left ventricular ejection fraction ≥ 40%
Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1) and diffusing capacity corrected for hemoglobin (DLCOc) ≥ 50% of predicted
Signed written informed consent
Female patients of childbearing potential must have a negative serum pregnancy test within 7 days of enrolment and must be willing to use an effective contraceptive method while enrolled in the study.

Who cannot join

Patient never treated with cytotoxic chemotherapy and planned conditioning regimen does not include 12 Gy TBI (exceptions allowed if approved by PI).
Allogeneic myeloablative transplant within 6 months.
Autologous hematopoietic stem cell transplant within 6 months.
Planned use of ATG in conditioning regimen (exceptions allowed if approved by PI in which case ATG must be adjusted for weight/lymphocyte count and given more than 1 week prior to transplant; any patient who receives ATG will have immune recovery studies but will not be counted with rest of patients and will be analyzed separately).
Planned use of an HLA matched CB (8/8 allele matched)
Uncontrolled infection.

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Presence of a malignancy other than the one for which the CB transplant is being performed, with an expected survival estimated to be less than 75% at 5 years.
Seropositivity for HIV.
Hepatitis B or C infection with measurable viral load. Patients with chronic hepatitis B or C infection regardless of viral load require clear documentation of absence of cirrhosis by either fibroscan or biopsy. If fibroscan is the method used, the test must be unequivocally negative.
Liver cirrhosis.
Active central nervous system involvement
Chloroma > 2 cm
≥50% blasts in marrow in an evaluable marrow sample (>25% of normal cellularity for age) collected less than one month prior to start of conditioning regimen.
Peripheral blasts >1000/mm3
Pregnancy, breastfeeding or unwillingness to use appropriate contraception.
Participation in a trial with an investigational agent within 30 days prior to entry in the study.
Patient unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up, and tests.
Any abnormal condition or laboratory result that is considered by the PI capable of altering patient's condition or study outcome.

Trial locations and contacts

1 site in 1 country.

Canada1 site

CIUSSS de l'Est-de-l'île-de Montreal, Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T2M4

Other trials in Canada

About this study

Official title: A Phase II Open-label Study of ECT-001-expanded Cord Blood Transplantation in Patients With High-risk Acute Leukemia/Myelodysplasia

Allogeneic hematopoietic stem cell transplantation is a life-saving procedure in patients with blood cancers. Cord blood (CB) represents an alternative source of stem cells, which is associated with a lower risk of relapse, especially in the presence of minimal residual disease in the setting of acute leukemia and myelodysplasia. Furthermore, CB has the added advantage of being associated with a low risk of chronic graft versus host disease (GVHD). Unfortunately, CB transplants are hampered by a higher risk of transplant related mortality (TRM) when compared to bone marrow/peripheral blood transplants because of the limited cell dose of CB.

In the previous UM171 trial (NCT02668315), the CB expansion protocol using the ECT-001-CB technology (UM171 molecule) has proven to be technically feasible and safe. UM171 expanded CB was associated with a median neutrophil recovery at day (D)+18 post transplant. Amongst 22 patients who received a single UM171 CB transplant with a median follow-up of 18 months, risk of TRM (5%) and grade 3-4 acute GVHD (10%) were low. There was no moderate-severe chronic GVHD. Thus, overall and progression free survival at 12 months were impressive at 90% and 74%, respectively. The UM171 expansion protocol allowed access to smaller, better HLA matched CBs as >80% of patients received a 6-7/8 HLA matched CB. Interestingly there were 5 patients who had already failed an allogeneic transplant and 5 patients with refractory/relapsed acute leukemia/aggressive lymphoma. Despite this high risk population, progression was 20% at 12 months. Hence, in this new trial, investigators are targeting patients with high and very high-risk acute leukemia/myelodysplasia to test the antileukemia effect of this new graft, a UM171 expanded CB.

Read the detailed description

Methodology:

This is a multi-center open label phase II clinical trial. Patients with high and very high-risk acute leukemia/myelodysplasia will receive a single 5-7/8 HLA matched ECT-001 (UM171) expanded cord blood after an ablative conditioning regimen. This group of patients would be expected to have poor progression free survival (PFS) after a conventional allogeneic transplant (bone marrow-peripheral blood).

Investigators key primary and secondary objectives include:

To confirm low Transplant Related Mortality (TRM)
To evaluate relapse free survival (RFS)
To analyze kinetics of hematologic engraftment;
To evaluate the incidence of acute and chronic GVHD
To evaluate the safety of the procedure
To evaluate incidence of infectious complications
To analyze duration of hospitalization
To evaluate the incidence of pre-engraftment/engraftment syndrome (PES/ES)
To analyze the effect of cryopreservation of the expanded CD34+ fraction on safety and efficacy endpoints

Conditions: High Risk Hematologic Malignancy, Cord Blood Transplant
Being tested: Transplant with an expanded ECT-001 cord blood
Keywords: UM171, Stem Cell Expansion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transplant with an expanded ECT-001 cord bloodBiological
1. Patients will receive a conditioning regimen (such as: cyclophosphamide 120 mg/kg, fludarabine 75mg/m2 and TBI 12 Gy or cyclophosphamide 50 mg/kg, fludarabine 150 mg/m2, thiotepa 10 mg/kg and TBI 4 Gy).
2. 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.
3. Patients will receive standard supportive care and GVHD prophylaxis (such as MMF and tacrolimus). Tacrolimus will be discontinued on Day 100 post-transplant unless GVHD arises.

Study groups in NCT03913026
Study group	Role	What they receive
Main intervention	Experimental	Eligible patients will receive an ablative conditioning regimen and be infused with an ECT-001 expanded cord-blood. The ECT-001 expanded CB could be infused fresh, or cryopreserved. Receives: Biological: Transplant with an expanded ECT-001 cord blood

What is being measured

The primary outcome is the main question the study is designed to answer.

Transplant Related Mortality (TRM)
TRM is defined as any death of any cause other than malignant relapse, occurring after the commencement of conditioning regimen that could be related to the transplantation procedure.
Measured: 1 year
Relapse Free survival (RFS)
RFS will be measured from time of transplant until disease relapse, death or last follow-up.
Measured: 2 years
Overall survival (OS)
OS will be measured from time of transplant until disease relapse, death or last follow-up.
Measured: 2 years

Secondary outcomes (9)

Neutrophil Engraftment
Time to neutrophil engraftment is defined as the first day of attainment of an absolute neutrophil count (ANC) ≥0.5 x 109/L for 3 consecutive days. Time to ANC ≥ 0.1 x 109/L will also be documented as it seems to predict TRM.
Measured: 42 days
Graft failure
Absence of neutrophil engraftment by day 42 or secondary graft failure without any obvious cause.
Measured: 42 days
Platelet Engraftment
Platelet engraftment is defined as the first day of a sustained platelet count ≥ 20 x 109/L with no platelet transfusion in the preceding 7 days as per CIBMTR standards (www.cibmtr.org).
Measured: 60 days
Incidence of Acute Graft Versus Host Disease (aGVHD)
The time to onset and maximal grade will be recorded. Acute GVHD will be defined as classic acute (time of onset of symptoms ≤ 100 days) or persistent, recurrent, or late onset acute GVHD (time of onset of symptoms > 100 days) as defined by the NIH. Results will be compared to patients at the same institution transplanted with different stem cell sources.
Measured: 1 year
Incidence of Chronic Graft Versus Host Disease (cGVHD)
Defined as per NIH global severity scores for mild, moderate, and severe chronic GVHD.
Measured: 2 years
Adverse events grade 3 or higher
All adverse events occurring during the clinical trial, including the protocol-defined post-treatment follow-up period, qualifying as a grade ≥ 3 toxicity per the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: 3 years
Incidence of severe infectious complications.
Any of the following infections requiring systemic therapy will be captured: invasive candidiasis, aspergillus, other invasive fungi, CMV, adenovirus, EBV, HHV-6, HSV, VZV, PCP, toxoplasmosis and mycobacterium.
Measured: 3 years
Hospitalization events
Total number of days admitted to the hospital in the first 100 days following transplant. Last day of fever (≥38.0°C) prior to engraftment, and number of days of parenteral feeding during transplant admission.
Measured: 1 year
Incidence of preengraftment/engraftment syndrome (ES) requiring therapy.
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 2019Jun 2027

First posted12 Apr 2019
Study start1 Apr 2019
Primary completionJun 2027 (estimated)
Study completionJun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for High Risk Hematologic MalignancyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03913026
Sponsor's protocol ID: ECT-001-CB.002
Status last verified: Oct 2025
First submitted: 9 Apr 2019
Last updated: 27 Oct 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Open-label Study of ECT-001-expanded Cord Blood Transplantation in Patients With High-risk Acute Leukemia/Myelodysplasia
ClinicalTrials.gov ID: NCT03913026
Acronym / sponsor ID: ECT-001-CB.002
Conditions: High Risk Hematologic Malignancy, Cord Blood Transplant
Keywords: UM171, Stem Cell Expansion
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 30 participants (estimated)
Lead sponsor: Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
Collaborators: Stem Cell Network, ExCellThera inc.
Study start: 1 Apr 2019 (actual)
Primary completion: Jun 2027 (estimated)
Study completion: Jun 2027 (estimated)
First posted: 12 Apr 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Methodology:

Investigators key primary and secondary objectives include:

To confirm low Transplant Related Mortality (TRM)
To evaluate relapse free survival (RFS)
To analyze kinetics of hematologic engraftment;
To evaluate the incidence of acute and chronic GVHD
To evaluate the safety of the procedure
To evaluate incidence of infectious complications
To analyze duration of hospitalization
To evaluate the incidence of pre-engraftment/engraftment syndrome (PES/ES)
To analyze the effect of cryopreservation of the expanded CD34+ fraction on safety and efficacy endpoints

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Main intervention	Experimental	Biological: Transplant with an expanded ECT-001 cord bloodEligible patients will receive an ablative conditioning regimen and be infused with an ECT-001 expanded cord-blood. The ECT-001 expanded CB could be infused fresh, or cryopreserved.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (42 listed)

Presence of high-risk acute leukemia/myelodysplasia defined as one of the following:
18-70 years old
Availability of 2 CBs ≥ 4/8 HLA match when A, B, C and DRB1 are performed at the allele level.
Karnofsky score ≥ 70%
Bilirubin < 2 x upper limit of normal (ULN) unless felt to be related to Gilbert's disease or hemolysis; AST and ALT ≤ 2.5 x ULN; alkaline phosphatase ≤ 5 x ULN.

Key exclusion criteria (18 listed)

Patient never treated with cytotoxic chemotherapy and planned conditioning regimen does not include 12 Gy TBI (exceptions allowed if approved by PI).
Allogeneic myeloablative transplant within 6 months.
Autologous hematopoietic stem cell transplant within 6 months.
Planned use of ATG in conditioning regimen (exceptions allowed if approved by PI in which case ATG must be adjusted for weight/lymphocyte count and given more than 1 week prior to transplant; any patient who receives ATG will have immune recovery studies but will not be counted with rest of patients and will be analyzed separately).
Planned use of an HLA matched CB (8/8 allele matched)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transplant with an expanded ECT-001 cord blood1. Patients will receive a conditioning regimen (such as: cyclophosphamide 120 mg/kg, fludarabine 75mg/m2 and TBI 12 Gy or cyclophosphamide 50 mg/kg, fludarabine 150 mg/m2, thiotepa 10 mg/kg and TBI 4 Gy). 2. 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. 3. Patients will receive standard supportive care and GVHD prophylaxis (such as MMF and tacrolimus). Tacrolimus will be discontinued on Day 100 post-transplant unless GVHD arises.	Biological	Main intervention

Primary outcome

Transplant Related Mortality (TRM)
Time frame: 1 year
TRM is defined as any death of any cause other than malignant relapse, occurring after the commencement of conditioning regimen that could be related to the transplantation procedure.
Relapse Free survival (RFS)
Time frame: 2 years
RFS will be measured from time of transplant until disease relapse, death or last follow-up.
Overall survival (OS)
Time frame: 2 years
OS will be measured from time of transplant until disease relapse, death or last follow-up.

9 secondary outcomes

Neutrophil Engraftment
Time frame: 42 days
Graft failure
Time frame: 42 days
Platelet Engraftment
Time frame: 60 days
Incidence of Acute Graft Versus Host Disease (aGVHD)
Time frame: 1 year
Incidence of Chronic Graft Versus Host Disease (cGVHD)
Time frame: 2 years
Adverse events grade 3 or higher
Time frame: 3 years
Incidence of severe infectious complications.
Time frame: 3 years
Hospitalization events
Time frame: 1 year
Incidence of preengraftment/engraftment syndrome (ES) requiring therapy.
Time frame: 30 days

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sandra Cohen, MD principal investigator

Ciusss de L'Est de l'Île de Montréal

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 42 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transplant Related Mortality (TRM) (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03913026.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.