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DC Vaccination for Post-remission Therapy in AML

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02405338
Recruitment Status : Completed
First Posted : April 1, 2015
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Medigene AG

Tracking Information
First Submitted Date  ICMJE March 24, 2015
First Posted Date  ICMJE April 1, 2015
Last Update Posted Date July 7, 2020
Actual Study Start Date  ICMJE March 2015
Actual Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2016)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 27, 2015)
  • Percentage of patients in whom treatment with the scheduled number of immunotherapies is feasible [ Time Frame: 2 years ]
  • Percentage of grade I/II and grade III/IV toxicities in patients having received at least 1 immunotherapy [ Time Frame: 2 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2015)
  • Induction of immune responses in patients having received at least 1 immunotherapy [ Time Frame: 2 years ]
  • Control of minimal residual disease (MRD) [ Time Frame: 2 years ]
  • Time to progression (TTP). [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DC Vaccination for Post-remission Therapy in AML
Official Title  ICMJE Dendritic Cell-based Active Immunotherapy of Patients With Acute Myeloid Leukemia Using Autologous Cells Transfected With RNA Encoding Two Different Leukemia-associated Antigens
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myeloid Leukemia
Intervention  ICMJE Biological: WT1/PRAME vaccination
Study Arms  ICMJE Experimental: WT1/PRAME vaccination
Intervention: Biological: WT1/PRAME vaccination
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 27, 2015)		 20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2019
Actual Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02405338
Other Study ID Numbers  ICMJE CD-FDC-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Medigene AG
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Medigene AG
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yngvar Fløisand Oslo University Hospital, Rikshospitalet Department of Hematology
PRS Account Medigene AG
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP