NCT02678338

Brief Summary

This phase I trial studies the side effects and best dose of anti-cluster of differentiation (CD)47 monoclonal antibody Hu5F9-G4 in treating patients with haematological malignancies including acute myeloid leukemia that has returned after a period of improvement (relapsed) or has not responded to previous treatment (refractory), or high risk myelodysplastic syndrome. Monoclonal antibodies, such as anti-CD47 monoclonal antibody Hu5F9-G4, block cancer growth in different ways by targeting certain cells.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2015

Typical duration for phase_1

Geographic Reach
1 country

5 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

Study Start

First participant enrolled

November 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

February 21, 2019

Status Verified

February 1, 2019

Enrollment Period

3 years

First QC Date

January 27, 2016

Last Update Submit

February 19, 2019

Conditions

Acute Myeloid LeukemiaMyelodysplastic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose (MTD) of Hu5F9-G4, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Part A)

    MTD is defined as the highest dosing schedule cohort level at which no more than 1 of 6 patients experience a Dose Limiting Toxicity (DLT).

    Up to 28 days

Study Arms (1)

Hu5F9-G4

EXPERIMENTAL

Dose Escalation: CD47 blocking antibody Hu5F9-G4

Drug: Hu5F9-G4

Interventions

Hu5F9-G4DRUG
Hu5F9-G4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically confirmed relapsed or refractory (primary refractory and relapsed refractory) Acute Myeloid Leukemia (AML) (defined by World Health Organization (WHO) criteria) for which no further conventional therapy is suitable for the patient, or confirmed myelodysplastic syndrome defined according to WHO classification, with an International Prognostic Scoring System (IPSS) risk category of intermediate-2 or high risk, that is relapsed, refractory or intolerant to conventional therapy within 3 weeks of registration.
  • Male or female, Age ≥ 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0-1
  • Willing to undergo blood transfusions as deemed clinically necessary.
  • Adequate hematological, liver, and kidney function

You may not qualify if:

  • Females: Pregnant or breast-feeding women, or women of childbearing potential unless effective method of contraception is used during and for 3 months after the trial. Males: unless an effective method of contraception is used during and for 3 months after the trial.
  • Any prior exposure to Hu5F9-G4 or other CD47 targeting agents.
  • Treatment with any other investigational agent within 28 days prior to enrolment.
  • Previous allogeneic stem cell transplant within 6 months prior to enrolment, active graft vs host disease (GVHD), or requiring transplant-related immunosuppression
  • Evidence for active CNS involvement by leukaemia
  • Clinical evidence or known history of cardiopulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University Hospital of Wales

Cardiff, United Kingdom

Location

St. James University Hospital

Leeds, United Kingdom

Location

The Royal Liverpool University Hospital

Liverpool, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, United Kingdom

Location

Churchill Hospital

Oxford, United Kingdom

Location

Related Publications (1)

  • Brierley CK, Staves J, Roberts C, Johnson H, Vyas P, Goodnough LT, Murphy MF. The effects of monoclonal anti-CD47 on RBCs, compatibility testing, and transfusion requirements in refractory acute myeloid leukemia. Transfusion. 2019 Jul;59(7):2248-2254. doi: 10.1111/trf.15397. Epub 2019 Jun 10.

    PMID: 31183877DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic Syndromes

Interventions

magrolimab

Condition Hierarchy (Ancestors)

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

Study Officials

  • Paresh Vyas, FRCP FRCPath

    University of Oxford

    PRINCIPAL INVESTIGATOR

  • Mark Chao, MD PhD

    Gilead Sciences

    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

January 27, 2016

First Posted

February 9, 2016

Study Start

November 1, 2015

Primary Completion

November 1, 2018

Study Completion

February 1, 2019

Last Updated

February 21, 2019

Record last verified: 2019-02

Locations

GB(5)