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DC Vaccination for Post-remission Therapy in AML

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ClinicalTrials.gov Identifier: NCT02405338
Recruitment Status : Active, not recruiting
First Posted : April 1, 2015
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Medigene AG

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.


Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Biological: WT1/PRAME vaccination Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: WT1/PRAME vaccination Biological: WT1/PRAME vaccination



Primary Outcome Measures :
  1. Percentage of patients in whom treatment with the scheduled number of immunotherapies is feasible [ Time Frame: 2 years ]
  2. Percentage of grade I/II, grade III/IV and grade ≥III toxicities in patients having received at least 1 immunotherapy [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]
  2. Relapse/Progression free survival [ Time Frame: 2 years ]
  3. Time to progression (TTP). [ Time Frame: 2 years ]
  4. Control of minimal residual disease (MRD) [ Time Frame: 2 years ]
  5. ECOG performance status [ Time Frame: 2 years ]
  6. Cellular immune responses to applied antigens [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02405338


Locations
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Norway
Oslo University Hospital, Rikshospitalet
Oslo, Norway, 0424
Sponsors and Collaborators
Medigene AG
Investigators
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Principal Investigator: Yngvar Fløisand Oslo University Hospital, Rikshospitalet Department of Hematology

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Responsible Party: Medigene AG
ClinicalTrials.gov Identifier: NCT02405338     History of Changes
Other Study ID Numbers: CD-FDC-001
First Posted: April 1, 2015    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Keywords provided by Medigene AG:
AML
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Vaccines
Immunologic Factors
Physiological Effects of Drugs