Acute Myeloid LeukemiaPhase 1NCT02678338
CAMELLIA: Anti-CD47 Antibody Therapy in Haematological Malignancies
A Phase 1 study testing Hu5F9-G4 in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Gilead Sciences at 5 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- What is being tested?
- Hu5F9-G4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Nov 2015to Feb 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
University Hospital of Wales
Cardiff
St. James University Hospital
Leeds
The Royal Liverpool University Hospital
Liverpool
The Christie NHS Foundation Trust
Manchester
Churchill Hospital
Oxford
About this study
Official title: A Phase I Dose Escalation Trial of the Humanized Anti-CD47 Monoclonal Antibody Hu5F9-G4 in Haematological Malignancies (CAMELLIA)
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.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- Being tested
- Hu5F9-G4
- 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.
Hu5F9-G4Drug
| Study group | Role | What they receive |
|---|---|---|
| Hu5F9-G4 | Experimental | Dose Escalation: CD47 blocking antibody Hu5F9-G4 Receives: Drug: Hu5F9-G4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startNov 2015
- Primary completionNov 2018
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- California Institute for Regenerative Medicine (CIRM)
- Responsible party
- Sponsor
- Investigators
- Paresh Vyas, FRCP FRCPath, Principal investigator, University of OxfordMark Chao, MD PhD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678338
- Sponsor's protocol ID
- SCI-CD47-002
- Other IDs
- 2015-000720-29, 2015
- Status last verified
- Feb 2019
- First submitted
- 27 Jan 2016
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31183877
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Trial of the Humanized Anti-CD47 Monoclonal Antibody Hu5F9-G4 in Haematological Malignancies (CAMELLIA)
- ClinicalTrials.gov ID
- NCT02678338
- Acronym / sponsor ID
- SCI-CD47-002
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Collaborators
- California Institute for Regenerative Medicine (CIRM)
- Study start
- Nov 2015 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 9 Feb 2016 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hu5F9-G4 | Experimental | Drug: Hu5F9-G4Dose Escalation: CD47 blocking antibody Hu5F9-G4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (6 listed)
- 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
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 |
|---|---|---|
| Hu5F9-G4 | Drug | Hu5F9-G4 |
Primary outcome
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)
Time frame: Up to 28 days
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).
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 21 Feb 2019.
- Derived from this study: PubMed 31183877Brierley 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.
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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.
Paresh Vyas, FRCP FRCPath principal investigator
University of Oxford
Mark Chao, MD PhD study director
Gilead Sciences
5 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 Hu5F9-G4 in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Gilead Sciences at 5 sites in United Kingdom.
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 5 inclusion and 6 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 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. 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?
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) (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02678338, which also lists 1 linked publication.
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 21 Feb 2019.