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Trial of AB-110 in Adults With Hematologic Malignancies Undergoing Cord Blood Transplantation

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ClinicalTrials.gov Identifier: NCT03483324
Recruitment Status : Not yet recruiting
First Posted : March 30, 2018
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Angiocrine Bioscience

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).

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Acute Lymphoblastic Leukemia in Remission Myelodysplastic Syndromes Other Acute Leukemias Biological: Unmanipulated Umbilical Cord Blood (UCB) Biological: AB-110 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Open-Label, Multi-Center Trial of AB-110 in Adults With Hematologic Malignancies Undergoing Cord
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : March 2022


Arm Intervention/treatment
Experimental: Experimental
Unmanipulated umbilical cord blood plus AB-110
Biological: Unmanipulated Umbilical Cord Blood (UCB)
Human leukocyte antigen (HLA) matched umbilical cord blood
Biological: AB-110
Expanded cord blood stem cells and engineered human endothelial cells



Primary Outcome Measures :
  1. Occurrence of adverse events grade 4 or grade 5 as assessed by CTCAEv4 [ Time Frame: 24 hours ]
  2. Graft failure defined as survival to day 42 without absolute neutrophil count greater than or equal to 500/mm3 [ Time Frame: 42 days ]

Secondary Outcome Measures :
  1. Time to neutrophil engraftment [ Time Frame: 42 days ]
  2. Cumulative incidence of sustained donor-derived neutrophil engraftment [ Time Frame: 42 days ]
  3. Cumulative incidence of sustained donor-derived neutrophil engraftment [ Time Frame: 100 days ]
  4. Cumulative incidence of sustained donor-derived neutrophil engraftment [ Time Frame: 180 days ]
  5. Incidence of engraftment syndrome [ Time Frame: 28 days ]
  6. Cumulative incidence of graft failure [ Time Frame: 43 days ]
  7. Cumulative incidence of graft failure [ Time Frame: 180 days ]
  8. Presence of post-transplant phenotype in hematopoietic cells of donor origin [ Time Frame: 180 days ]
  9. Cumulative incidence of grade II - IV acute graft versus host disease (aGVHD) [ Time Frame: 100 days ]
  10. Cumulative incidence of grade II - IV acute graft versus host disease (GVHD) [ Time Frame: 180 days ]
  11. Cumulative incidence of chronic GVHD [ Time Frame: 100 days ]
  12. Cumulative incidence of chronic GVHD [ Time Frame: 180 days ]
  13. Time to lymphoid recovery [ Time Frame: 180 days ]
  14. Cumulative incidence of transplant related mortality (TRM) [ Time Frame: 100 days ]
  15. Cumulative incidence of transplant related mortality (TRM) [ Time Frame: 180 days ]
  16. Overall survival (OS) [ Time Frame: 100 days ]
  17. Overall survival (OS) [ Time Frame: 180 days ]
  18. Disease Free Survival (DFS) [ Time Frame: 100 days ]
  19. Disease Free Survival (DFS) [ Time Frame: 180 days ]

Other Outcome Measures:
  1. Late onset acute GVHD [ Time Frame: 720 days ]
  2. Chronic GVHD [ Time Frame: 720 days ]
  3. Quantitative recovery of T-cells and subsets [ Time Frame: 1 year ]
  4. Quantitative recovery of T-cells and subsets [ Time Frame: 2 years ]
  5. Transplant Related Mortality [ Time Frame: 1 year ]
  6. Transplant Related Mortality [ Time Frame: 2 years ]
  7. Recurrence of malignancy [ Time Frame: 1 year ]
  8. Recurrence of malignancy [ Time Frame: 2 years ]
  9. Overall survival [ Time Frame: 1 year ]
  10. Overall survival [ Time Frame: 2 years ]
  11. Disease free survival [ Time Frame: 1 year ]
  12. Disease free survival [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have received some immunosuppressive chemotherapy in the preceding 3 months.
  • Acute myelogenous leukemia (AML):

    1. Complete first remission (CR1) at high risk for relapse
    2. Complete second remission (CR2).
    3. No documented myelofibrosis at screening marrow biopsy
  • Acute lymphoblastic leukemia (ALL):

    1. Complete first remission (CR1) at high risk for relapse
    2. 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:

    1. A negative serum pregnancy test
    2. 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483324


Contacts
Contact: Shawn Sheeron 215-796-3286 ssheeron@angiocrinebio.com
Contact: John Jaskowiak 408-646-2265 jjaskowiak@angiocrinebio.com

Locations
United States, California
City of Hope Comprehensive Cancer Center Not yet recruiting
Duarte, California, United States, 91010
Contact: Rie Miyahira    626-256-4673 ext 80032    rmiyahira@coh.org   
Principal Investigator: Chatchada Karanes, MD         
United States, Colorado
University of Colorado Cancer Center University of Colorado Anschutz Medical Campus Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Derek Schatz    720-848-0628    derek.schatz@ucdenver.edu   
Principal Investigator: Jonathan Gutman, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
Contact: Beth Hoover    646-888-8570    hoovere@mskcc.org   
Principal Investigator: Juliet Barker, MBBS         
Sponsors and Collaborators
Angiocrine Bioscience
Investigators
Study Director: Paul Finegan, MD Angiocrine Bioscience
Principal Investigator: Juliet Barker, MBBS Memorial Sloan Kettering Cancer Center

Responsible Party: Angiocrine Bioscience
ClinicalTrials.gov Identifier: NCT03483324     History of Changes
Other Study ID Numbers: AB-110-001
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases