Leukemia, Myeloid, AcutePhase 1NCT02493829
B7.1/IL-2 Leukaemia Cell Vaccine for Non-Transplant AML RFUSIN2-AML2 (NTX)
A Phase 1 study testing AML Cell Vaccine in people with Leukemia, Myeloid, Acute and Myelodysplastic Syndromes, run by King's College London.
Trial summary
The study will be an open label, single arm, phase I study intended to identify the safety and tolerability of "AML Cell Vaccine" given to eligible MDS RAEB-2 and AML patients who have achieved a best response of complete remission or partial remission following their first or second course of standard induction… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
- What is being tested?
- AML Cell Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- May 2017to May 2020
- 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
- Diagnosis of MDS RAEB-2 or primary (de novo) or secondary AML defined according to the WHO classification either as a new diagnosis or as a relapse.
- Patients for whom the optimal therapy in CR1 would be to undergo allogeneic bone marrow transplantation, but for whom this procedure is either not recommended (e.g. due to comorbidities) or not available (e.g. lack of a suitable donor).
Who cannot join
- Patients with MDS RAEB-2 or AML and favourable prognostic profile (good risk cytogenetics: t(15;17)(q22;q12~21), inv16(p13q22)/t(16;16)(p13;q22), t(8;21)(q22;q22) or cytogenetically normal AML with NPM1 mutation and absence of Flt-3 ITD).
- Patients unsuitable for standard induction chemotherapy.
- Patients who have previously undergone or will be able to undergo allogeneic transplantation.
- Patients who have had previous or current treatment with any form of investigational immunotherapy.
About this study
Official title: A Phase I Study of B7.1 (CD80)/IL-2 Immune Gene Therapy for High Risk MDS RAEB-2 and Acute Myeloid Leukaemia Patients Unsuitable for Allogeneic Haematological Stem Cell Transplant
The study will be an open label, single arm, phase I study intended to identify the safety and tolerability of "AML Cell Vaccine" given to eligible MDS RAEB-2 and AML patients who have achieved a best response of complete remission or partial remission following their first or second course of standard induction chemotherapy.
- Being tested
- AML Cell Vaccine
- 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.
AML Cell VaccineBiological
| Study group | Role | What they receive |
|---|---|---|
| AML Cell Vaccine | Experimental | Not described Receives: Biological: AML Cell Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine-related toxicity based on the NCI criteria V4.0
Measured: 52 weeks
Frequency, severity of adverse events to the AML cell vaccine
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startMay 2017 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493829
- Sponsor's protocol ID
- 2494
- Status last verified
- Apr 2017
- First submitted
- 9 Jun 2015
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of B7.1 (CD80)/IL-2 Immune Gene Therapy for High Risk MDS RAEB-2 and Acute Myeloid Leukaemia Patients Unsuitable for Allogeneic Haematological Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT02493829
- Acronym / sponsor ID
- 2494
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Study start
- May 2017 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 10 Jul 2015 (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.
The study will be an open label, single arm, phase I study intended to identify the safety and tolerability of "AML Cell Vaccine" given to eligible MDS RAEB-2 and AML patients who have achieved a best response of complete remission or partial remission following their first or second course of standard induction chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AML Cell Vaccine | Experimental | Biological: AML Cell Vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of MDS RAEB-2 or primary (de novo) or secondary AML defined according to the WHO classification either as a new diagnosis or as a relapse.
- Patients for whom the optimal therapy in CR1 would be to undergo allogeneic bone marrow transplantation, but for whom this procedure is either not recommended (e.g. due to comorbidities) or not available (e.g. lack of a suitable donor).
Key exclusion criteria (4 listed)
- Patients with MDS RAEB-2 or AML and favourable prognostic profile (good risk cytogenetics: t(15;17)(q22;q12~21), inv16(p13q22)/t(16;16)(p13;q22), t(8;21)(q22;q22) or cytogenetically normal AML with NPM1 mutation and absence of Flt-3 ITD).
- Patients unsuitable for standard induction chemotherapy.
- Patients who have previously undergone or will be able to undergo allogeneic transplantation.
- Patients who have had previous or current treatment with any form of investigational immunotherapy.
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 |
|---|---|---|
| AML Cell Vaccine | Biological | AML Cell Vaccine |
Primary outcome
Vaccine-related toxicity based on the NCI criteria V4.0
Time frame: 52 weeks
Frequency, severity of adverse events to the AML cell vaccine
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AML Cell Vaccine in people with Leukemia, Myeloid, Acute and Myelodysplastic Syndromes, run by King's College London.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Vaccine-related toxicity based on the NCI criteria V4.0 (time frame: 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2017.