NCT03483324

Brief 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. Subjects will receive unmanipulated cord blood (UCB) and AB-110 expanded CD34 enriched hematopoietic progenitor cells (HSPC).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2018

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
25 days until next milestone

Study Start

First participant enrolled

April 24, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

May 31, 2022

Status Verified

May 1, 2022

Enrollment Period

2.7 years

First QC Date

March 23, 2018

Last Update Submit

May 26, 2022

Conditions

Acute Myeloid LeukemiaAcute Lymphoblastic Leukemia in RemissionMyelodysplastic SyndromesOther Acute Leukemias

Outcome Measures

Primary Outcomes (2)

  • Occurrence of adverse events grade 4 or grade 5 as assessed by CTCAEv4

    24 hours

  • Graft failure defined as survival to day 42 without absolute neutrophil count greater than or equal to 500/mm3

    42 days

Secondary Outcomes (19)

  • Time to neutrophil engraftment

    42 days

  • Cumulative incidence of sustained donor-derived neutrophil engraftment

    42 days

  • Cumulative incidence of sustained donor-derived neutrophil engraftment

    100 days

  • Cumulative incidence of sustained donor-derived neutrophil engraftment

    180 days

  • Incidence of engraftment syndrome

    28 days

  • +14 more secondary outcomes

Other Outcomes (12)

  • Late onset acute GVHD

    720 days

  • Chronic GVHD

    720 days

  • Quantitative recovery of T-cells and subsets

    1 year

  • +9 more other outcomes

Study Arms (1)

Experimental

EXPERIMENTAL

Unmanipulated umbilical cord blood plus AB-110

Biological: Unmanipulated Umbilical Cord Blood (UCB)Biological: AB-110

Interventions

Unmanipulated Umbilical Cord Blood (UCB)BIOLOGICAL

Human leukocyte antigen (HLA) matched umbilical cord blood

Experimental
AB-110BIOLOGICAL

Expanded cord blood stem cells and engineered human endothelial cells

Experimental

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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):
  • 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.
  • +15 more criteria

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

University of Colorado Cancer Center University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic Syndromes

Interventions

epithienamycin E

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Study Officials

  • Paul Finnegan, MD

    Angiocrine Bioscience

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2018

First Posted

March 30, 2018

Study Start

April 24, 2018

Primary Completion

December 21, 2020

Study Completion

January 31, 2022

Last Updated

May 31, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(3)