DC Vaccination for Post-remission Therapy in AML

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02405338
• Other study ID #: CD-FDC-001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2015
• Est. completion date: November 2019

Study information

• Verified date: July 2019
• Source: Medigene AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Biological:
• WT1/PRAME vaccination

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Rikshospitalet	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Medigene AG

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients in whom treatment with the scheduled number of immunotherapies is feasible		2 years
Primary	Percentage of grade I/II, grade III/IV and grade =III toxicities in patients having received at least 1 immunotherapy		2 years
Secondary	Overall survival		2 years
Secondary	Relapse/Progression free survival		2 years
Secondary	Time to progression (TTP).		2 years
Secondary	Control of minimal residual disease (MRD)		2 years
Secondary	ECOG performance status		2 years
Secondary	Cellular immune responses to applied antigens		2 years