Acute Myeloid LeukemiaPhase 1/2NCT02405338
DC Vaccination for Post-remission Therapy in AML
A Phase 1/2 study testing WT1/PRAME vaccination in people with Acute Myeloid Leukemia, run by Medigene AG at 1 site in Norway.
Trial summary
This is a multi-centre, open label, prospective, non-randomized phase I/II trial in 20 patients including a safety-run in phase I part comprising 6 patients. Trial subjects will receive repeated immunotherapies with autologous Dendritic Cells (DCs), presenting two leukemia-associated antigens. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- WT1/PRAME vaccination
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2015to Nov 2019
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Acute Myeloid Leukemia (AML)
- Age 18 - 75 years
- Morphologic remission (CR) with or without hematological recovery (CRi) following induction chemotherapy
- WT1 with or without PRAME positivity by qPCR
- Negative pregnancy test in women of childbearing potential (within 7 days before the first vaccination). Women of childbearing potential and sexually active male participants must use reliable methods of contraception during the whole treatment period and 3 months after the last trial drug dose
- Negative HIV 1 and 2 test, Hepatitis B and C test and negative Syphilis test at screening
- Informed consent signed prior to any trial related activities
Who cannot join
- Patients suitable for allogeneic stem cell transplantation
- AML M3 (acute promyelocytic leukemia)
- Patients not in complete remission (CR or CRi), bone marrow blast count ≥ 5 %
- Active immunodeficiency syndromes
- Concurrent active second malignancy other than non-melanoma skin cancers
- Clinically relevant autoimmune disease
Show all 19Show fewer
- Prior immunotherapy
- Severe organ dysfunction precluding the apheresis procedure:
- Creatinine > 200 mmol/l
- Bilirubin, ALAT and ASAT > 3 x upper normal limit
- Respiratory insufficiency with pO2 < 60 mmHg
- Clinically relevant coronary heart disease of ventricular arrhythmia, congestive heart failure > grade II NYHA
- Recent cerebral hemorrhage
- Known allergies to substances used in the generation of DCs
- Other severe acute or chronic medical psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or the administration of the investigational product
- Use of corticosteroids
- Active CMV infection (Antibody-positivity due to previous, now inactive infection is accepted)
- Inability to comply with the trial protocol
- Participation in other clinical trials that, according to the investigator's discretion, may interfere with this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dendritic Cell-based Active Immunotherapy of Patients With Acute Myeloid Leukemia Using Autologous Cells Transfected With RNA Encoding Two Different Leukemia-associated Antigens
This is a multi-centre, open label, prospective, non-randomized phase I/II trial in 20 patients including a safety-run in phase I part comprising 6 patients.
Trial subjects will receive repeated immunotherapies with autologous Dendritic Cells (DCs), presenting two leukemia-associated antigens.
Read the detailed description
20 patients with AML who are in remission (ELN criteria by Döhner et al 2017) receive WT1/PRAME autologous DC vaccine by intradermal injection once per week during the first 4 weeks and 1 per month thereafter for 23 consecutive months.
Primary objective is to assess the safety and tolerability of the DC vaccine in the aforementioned population and the feasibility.
Secondary objectives include evaluation of clinical response and exploratory immune monitoring assessments.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- WT1/PRAME vaccination
- Keywords
- AML
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WT1/PRAME vaccinationBiological
| Study group | Role | What they receive |
|---|---|---|
| WT1/PRAME vaccination | Experimental | Not described Receives: Biological: WT1/PRAME vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients in whom treatment with the scheduled number of immunotherapies is feasible
Measured: 2 years
Percentage of grade I/II, grade III/IV and grade ≥III toxicities in patients having received at least 1 immunotherapy
Measured: 2 years
Secondary outcomes (6)
Overall survival
Measured: 2 years
Relapse/Progression free survival
Measured: 2 years
Time to progression (TTP).
Measured: 2 years
Control of minimal residual disease (MRD)
Measured: 2 years
ECOG performance status
Measured: 2 years
Cellular immune responses to applied antigens
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medigene AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yngvar Fløisand, Principal investigator, Oslo University Hospital, Rikshospitalet Department of Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405338
- Sponsor's protocol ID
- CD-FDC-001
- Status last verified
- Jul 2019
- First submitted
- 24 Mar 2015
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dendritic Cell-based Active Immunotherapy of Patients With Acute Myeloid Leukemia Using Autologous Cells Transfected With RNA Encoding Two Different Leukemia-associated Antigens
- ClinicalTrials.gov ID
- NCT02405338
- Acronym / sponsor ID
- CD-FDC-001
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medigene AGIndustry (pharma, biotech, devices)
- Study start
- Mar 2015 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 1 Apr 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.
This is a multi-centre, open label, prospective, non-randomized phase I/II trial in 20 patients including a safety-run in phase I part comprising 6 patients.
Trial subjects will receive repeated immunotherapies with autologous Dendritic Cells (DCs), presenting two leukemia-associated antigens.
Detailed description
20 patients with AML who are in remission (ELN criteria by Döhner et al 2017) receive WT1/PRAME autologous DC vaccine by intradermal injection once per week during the first 4 weeks and 1 per month thereafter for 23 consecutive months.
Primary objective is to assess the safety and tolerability of the DC vaccine in the aforementioned population and the feasibility.
Secondary objectives include evaluation of clinical response and exploratory immune monitoring assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WT1/PRAME vaccination | Experimental | Biological: WT1/PRAME vaccination |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of Acute Myeloid Leukemia (AML)
- Age 18 - 75 years
- Morphologic remission (CR) with or without hematological recovery (CRi) following induction chemotherapy
- WT1 with or without PRAME positivity by qPCR
- Negative pregnancy test in women of childbearing potential (within 7 days before the first vaccination). Women of childbearing potential and sexually active male participants must use reliable methods of contraception during the whole treatment period and 3 months after the last trial drug dose
Key exclusion criteria (19 listed)
- Patients suitable for allogeneic stem cell transplantation
- AML M3 (acute promyelocytic leukemia)
- Patients not in complete remission (CR or CRi), bone marrow blast count ≥ 5 %
- Active immunodeficiency syndromes
- Concurrent active second malignancy other than non-melanoma skin cancers
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 |
|---|---|---|
| WT1/PRAME vaccination | Biological | WT1/PRAME vaccination |
Primary outcome
Percentage of patients in whom treatment with the scheduled number of immunotherapies is feasible
Time frame: 2 years
Percentage of grade I/II, grade III/IV and grade ≥III toxicities in patients having received at least 1 immunotherapy
Time frame: 2 years
6 secondary outcomes
Overall survival
Time frame: 2 years
Relapse/Progression free survival
Time frame: 2 years
Time to progression (TTP).
Time frame: 2 years
Control of minimal residual disease (MRD)
Time frame: 2 years
ECOG performance status
Time frame: 2 years
Cellular immune responses to applied antigens
Time frame: 2 years
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 7 Jul 2020.
Related trials for Acute Myeloid Leukemia
RecruitingPhase 3
Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
Acute Promyelocytic Leukemia (APL), Acute Promyelocytic Leukaemia
Active, not recruiting
High-Intensity Parent Intervention Program in Improving Learning and School Functioning in Latino Children With Acute Leukemia or Lymphoblastic Lymphoma
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 1
Study of REM-422 in Patients With AML or Higher Risk MDS
Myelodysplastic Syndromes, Higher Risk Myelodysplastic Syndromes
Not yet recruiting
my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults
Sarcoma, Osteosarcoma
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.
Yngvar Fløisand principal investigator
Oslo University Hospital, Rikshospitalet Department of Hematology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing WT1/PRAME vaccination in people with Acute Myeloid Leukemia, run by Medigene AG at 1 site in Norway.
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 7 inclusion and 19 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 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percentage of patients in whom treatment with the scheduled number of immunotherapies is feasible (time frame: 2 years). 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 7 Jul 2020.