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CAMELLIA: Anti-CD47 Antibody Therapy in Haematological Malignancies

Primary Purpose

Acute Myeloid Leukemia, Myelodysplastic Syndrome

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Hu5F9-G4
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

Sites / Locations

  • University Hospital of Wales
  • St. James University Hospital
  • The Royal Liverpool University Hospital
  • The Christie NHS Foundation Trust
  • Churchill Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hu5F9-G4

Arm Description

Dose Escalation: CD47 blocking antibody Hu5F9-G4

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
January 27, 2016
Last Updated
February 19, 2019
Sponsor
Gilead Sciences
Collaborators
California Institute for Regenerative Medicine (CIRM)
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1. Study Identification

Unique Protocol Identification Number
NCT02678338
Brief Title
CAMELLIA: Anti-CD47 Antibody Therapy in Haematological Malignancies
Official Title
A Phase I Dose Escalation Trial of the Humanized Anti-CD47 Monoclonal Antibody Hu5F9-G4 in Haematological Malignancies (CAMELLIA)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
Collaborators
California Institute for Regenerative Medicine (CIRM)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Myelodysplastic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hu5F9-G4
Arm Type
Experimental
Arm Description
Dose Escalation: CD47 blocking antibody Hu5F9-G4
Intervention Type
Drug
Intervention Name(s)
Hu5F9-G4
Primary Outcome Measure Information:
Title
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)
Description
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).
Time Frame
Up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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 Key Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paresh Vyas, FRCP FRCPath
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Chao, MD PhD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital of Wales
City
Cardiff
Country
United Kingdom
Facility Name
St. James University Hospital
City
Leeds
Country
United Kingdom
Facility Name
The Royal Liverpool University Hospital
City
Liverpool
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31183877
Citation
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.
Results Reference
derived

Learn more about this trial

CAMELLIA: Anti-CD47 Antibody Therapy in Haematological Malignancies

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