DC Vaccination for Post-remission Therapy in AML

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02405338
• Date of registration: 24/03/2015
• Prospective Registration: No
• Primary sponsor: Medigene AG
• Public title: DC Vaccination for Post-remission Therapy in AML
• Scientific title: Dendritic Cell-based Active Immunotherapy of Patients With Acute Myeloid Leukemia Using Autologous Cells Transfected With RNA Encoding Two Different Leukemia-associated Antigens
• Date of first enrolment: March 2015
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02405338
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Norway

Contacts

• Name: Yngvar Fløisand
• Affiliation: Oslo University Hospital, Rikshospitalet Department of Hematology

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Acute Myeloid Leukemia

Intervention(s)

Biological: WT1/PRAME vaccination

Primary Outcome(s)

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]

Secondary Outcome(s)

Control of minimal residual disease (MRD) [Time Frame: 2 years]

Time to progression (TTP). [Time Frame: 2 years]

Cellular immune responses to applied antigens [Time Frame: 2 years]

ECOG performance status [Time Frame: 2 years]

Relapse/Progression free survival [Time Frame: 2 years]

Overall survival [Time Frame: 2 years]

Secondary ID(s)

CD-FDC-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors