DC Vaccination for Post-remission Therapy in AML

July 6, 2020 updated by: Medigene AG

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

Completed

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

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Oslo, Norway, 0424
        • Oslo University Hospital, Rikshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Yngvar Fløisand, Oslo University Hospital, Rikshospitalet Department of Hematology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

March 24, 2015

First Submitted That Met QC Criteria

March 27, 2015

First Posted (Estimate)

April 1, 2015

Study Record Updates

Last Update Posted (Actual)

July 7, 2020

Last Update Submitted That Met QC Criteria

July 6, 2020

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

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.

Clinical Trials on Acute Myeloid Leukemia

Clinical Trials on WT1/PRAME vaccination

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