Acute Myeloid LeukemiaPhase 1NCT03483324
Trial of AB-110 in Adults With Hematologic Malignancies Undergoing Cord Blood Transplantation
A Phase 1 study testing Unmanipulated Umbilical Cord Blood (UCB) and AB-110 in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia in Remission, run by Angiocrine Bioscience at 3 sites in United States.
Trial summary
A phase 1b, open label, multi-center trial of AB-110 in adults with hematologic malignancies, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplasia (MDS) undergoing cord blood transplantation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia in Remission, Myelodysplastic Syndromes
- What is being tested?
- Unmanipulated Umbilical Cord Blood (UCB) and AB-110
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Apr 2018to 31 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must have received some immunosuppressive chemotherapy in the preceding 3 months.
- Acute myelogenous leukemia (AML):
- Complete first remission (CR1) at high risk for relapse
- Complete second remission (CR2).
- No documented myelofibrosis at screening marrow biopsy
- Acute lymphoblastic leukemia (ALL):
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- Complete first remission (CR1) at high risk for relapse
- Complete second remission (CR2).
- Other acute leukemias that are of ambiguous lineage or of other types
- Any acute leukemia with marrow aplasia or without adequate count recovery.
- Myelodysplastic Syndrome (MDS)
- Karnofsky score > 70 %.
- Calculated creatinine clearance > 60 ml/min.
- Bilirubin < 1.5 mg/dL, ALT < 3 x upper limit of normal
- Pulmonary function (FVC, FEV1 and corrected DLCO) > 50% predicted.
- Left ventricular ejection fraction > 50%.
- Albumin > 3.0 g/dL.
- Negative antiviral serology:
- Negative human immunodeficiency virus (HIV) antibody.
- Negative human T-lymphotropic virus (HTLV)-1 and 2 antibodies.
- Negative hepatitis B surface antigen (HBsAg) and undetectable hepatitis B virus (HBV) DNA
- Negative hepatitis C virus (HCV) antibody or negative HCV ribonucleic acid (RNA)
- For female subjects of childbearing potential:
- A negative serum pregnancy test
- Willing to use contraception throughout the study period.
- Male subjects must be willing to use a recommended method of contraception throughout the study period, and to refrain from sperm donation throughout the study period.
- Two appropriate CB units identified for the subject.
- In the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the subject's cancer.
- Willingness and ability to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions.
- Evidence of a signed informed written consent
Who cannot join
- Pregnancy or breastfeeding.
- Current active, uncontrolled bacterial, viral, or fungal infection
- Prior allogeneic or autologous HCT at any time.
- Active malignancy other than the one for which AB-110 transplant is being performed within 12 months of enrollment.
- Any identified and available 10/10 HLA-matched related donor or 10/10 HLA-matched unrelated donor.
- Have evidence of recipient donor specific anti-HLA antibodies.
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- Active central nervous system (CNS) disease at time of screening.
- Documented allergy to DMSO, mouse or bovine proteins, or iron.
- Subject has other conditions that in the opinion of the investigator would place the subject at increased risk for toxicity by participation in the study.
- Psychiatric condition making the patient unlikely to comply with protocol therapy, required tests and follow-up.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado Cancer Center University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Phase 1 Open-Label, Multi-Center Trial of AB-110 in Adults With Hematologic Malignancies Undergoing Cord
A phase 1b, open label, multi-center trial of AB-110 in adults with hematologic malignancies, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplasia (MDS) undergoing cord blood transplantation. Subjects will receive unmanipulated cord blood (UCB) and AB-110 expanded CD34 enriched hematopoietic progenitor cells (HSPC).
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia in Remission, Myelodysplastic Syndromes, Other Acute Leukemias
- Being tested
- Unmanipulated Umbilical Cord Blood (UCB), AB-110
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unmanipulated Umbilical Cord Blood (UCB)Biological
Human leukocyte antigen (HLA) matched umbilical cord blood
AB-110Biological
Expanded cord blood stem cells and engineered human endothelial cells
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Unmanipulated umbilical cord blood plus AB-110 Receives: Biological: Unmanipulated Umbilical Cord Blood (UCB); Biological: AB-110 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events grade 4 or grade 5 as assessed by CTCAEv4
Measured: 24 hours
Graft failure defined as survival to day 42 without absolute neutrophil count greater than or equal to 500/mm3
Measured: 42 days
Secondary outcomes (19)
Time to neutrophil engraftment
Measured: 42 days
Cumulative incidence of sustained donor-derived neutrophil engraftment
Measured: 42 days
Cumulative incidence of sustained donor-derived neutrophil engraftment
Measured: 100 days
Cumulative incidence of sustained donor-derived neutrophil engraftment
Measured: 180 days
Incidence of engraftment syndrome
Measured: 28 days
Cumulative incidence of graft failure
Measured: 43 days
Cumulative incidence of graft failure
Measured: 180 days
Presence of post-transplant phenotype in hematopoietic cells of donor origin
Measured: 180 days
Cumulative incidence of grade II - IV acute graft versus host disease (aGVHD)
Measured: 100 days
Cumulative incidence of grade II - IV acute graft versus host disease (GVHD)
Measured: 180 days
Cumulative incidence of chronic GVHD
Measured: 100 days
Cumulative incidence of chronic GVHD
Measured: 180 days
Time to lymphoid recovery
Measured: 180 days
Cumulative incidence of transplant related mortality (TRM)
Measured: 100 days
Cumulative incidence of transplant related mortality (TRM)
Measured: 180 days
Overall survival (OS)
Measured: 100 days
Overall survival (OS)
Measured: 180 days
Disease Free Survival (DFS)
Measured: 100 days
Disease Free Survival (DFS)
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start24 Apr 2018
- Primary completion21 Dec 2020
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angiocrine Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- California Institute for Regenerative Medicine (CIRM)
- Responsible party
- Sponsor
- Investigators
- Paul Finnegan, MD, Study director, Angiocrine Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483324
- Sponsor's protocol ID
- AB-110-001
- Status last verified
- May 2022
- First submitted
- 23 Mar 2018
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label, Multi-Center Trial of AB-110 in Adults With Hematologic Malignancies Undergoing Cord
- ClinicalTrials.gov ID
- NCT03483324
- Acronym / sponsor ID
- AB-110-001
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia in Remission, Myelodysplastic Syndromes, Other Acute Leukemias
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Angiocrine BioscienceIndustry (pharma, biotech, devices)
- Collaborators
- California Institute for Regenerative Medicine (CIRM)
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 30 Mar 2018 (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.
A phase 1b, open label, multi-center trial of AB-110 in adults with hematologic malignancies, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplasia (MDS) undergoing cord blood transplantation. Subjects will receive unmanipulated cord blood (UCB) and AB-110 expanded CD34 enriched hematopoietic progenitor cells (HSPC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Biological: Unmanipulated Umbilical Cord Blood (UCB), Biological: AB-110Unmanipulated umbilical cord blood plus AB-110 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (30 listed)
- Patients must have received some immunosuppressive chemotherapy in the preceding 3 months.
- Acute myelogenous leukemia (AML):
- Acute lymphoblastic leukemia (ALL):
- Other acute leukemias that are of ambiguous lineage or of other types
- Any acute leukemia with marrow aplasia or without adequate count recovery.
Key exclusion criteria (10 listed)
- Pregnancy or breastfeeding.
- Current active, uncontrolled bacterial, viral, or fungal infection
- Prior allogeneic or autologous HCT at any time.
- Active malignancy other than the one for which AB-110 transplant is being performed within 12 months of enrollment.
- Any identified and available 10/10 HLA-matched related donor or 10/10 HLA-matched unrelated donor.
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 |
|---|---|---|
| Unmanipulated Umbilical Cord Blood (UCB)Human leukocyte antigen (HLA) matched umbilical cord blood | Biological | Experimental |
| AB-110Expanded cord blood stem cells and engineered human endothelial cells | Biological | Experimental |
Primary outcome
Occurrence of adverse events grade 4 or grade 5 as assessed by CTCAEv4
Time frame: 24 hours
Graft failure defined as survival to day 42 without absolute neutrophil count greater than or equal to 500/mm3
Time frame: 42 days
19 secondary outcomes
Time to neutrophil engraftment
Time frame: 42 days
Cumulative incidence of sustained donor-derived neutrophil engraftment
Time frame: 42 days
Cumulative incidence of sustained donor-derived neutrophil engraftment
Time frame: 100 days
Cumulative incidence of sustained donor-derived neutrophil engraftment
Time frame: 180 days
Incidence of engraftment syndrome
Time frame: 28 days
Cumulative incidence of graft failure
Time frame: 43 days
Cumulative incidence of graft failure
Time frame: 180 days
Presence of post-transplant phenotype in hematopoietic cells of donor origin
Time frame: 180 days
Cumulative incidence of grade II - IV acute graft versus host disease (aGVHD)
Time frame: 100 days
Cumulative incidence of grade II - IV acute graft versus host disease (GVHD)
Time frame: 180 days
Cumulative incidence of chronic GVHD
Time frame: 100 days
Cumulative incidence of chronic GVHD
Time frame: 180 days
Time to lymphoid recovery
Time frame: 180 days
Cumulative incidence of transplant related mortality (TRM)
Time frame: 100 days
Cumulative incidence of transplant related mortality (TRM)
Time frame: 180 days
Overall survival (OS)
Time frame: 100 days
Overall survival (OS)
Time frame: 180 days
Disease Free Survival (DFS)
Time frame: 100 days
Disease Free Survival (DFS)
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Individual participant dataSharing planned: No
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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.
Paul Finnegan, MD study director
Angiocrine Bioscience
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Unmanipulated Umbilical Cord Blood (UCB) and AB-110 in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia in Remission, run by Angiocrine Bioscience at 3 sites in United States.
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 30 inclusion and 10 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: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of adverse events grade 4 or grade 5 as assessed by CTCAEv4 (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.