- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02405338
DC Vaccination for Post-remission Therapy in AML
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Oslo, Norway, 0424
- Oslo University Hospital, Rikshospitalet
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: WT1/PRAME vaccination
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of patients in whom treatment with the scheduled number of immunotherapies is feasible
Time Frame: 2 years
|
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
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 2 years
|
2 years
|
Relapse/Progression free survival
Time Frame: 2 years
|
2 years
|
Time to progression (TTP).
Time Frame: 2 years
|
2 years
|
Control of minimal residual disease (MRD)
Time Frame: 2 years
|
2 years
|
ECOG performance status
Time Frame: 2 years
|
2 years
|
Cellular immune responses to applied antigens
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yngvar Fløisand, Oslo University Hospital, Rikshospitalet Department of Hematology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CD-FDC-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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