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DC Vaccination for Post-remission Therapy in AML

Primary Purpose

Acute Myeloid Leukemia

Status

Completed

Phase

Phase 1

Locations

Norway

Study Type

Interventional

Intervention

WT1/PRAME vaccination

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Oslo University Hospital, Rikshospitalet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WT1/PRAME vaccination

Arm Description

Outcomes

Primary Outcome Measures

Percentage of patients in whom treatment with the scheduled number of immunotherapies is feasible

Percentage of grade I/II, grade III/IV and grade ≥III toxicities in patients having received at least 1 immunotherapy

Secondary Outcome Measures

Overall survival

Relapse/Progression free survival

Time to progression (TTP).

Control of minimal residual disease (MRD)

ECOG performance status

Cellular immune responses to applied antigens

Full Information

NCT ID

NCT02405338

First Posted

March 24, 2015

Last Updated

July 6, 2020

Sponsor

Medigene AG

1. Study Identification

Unique Protocol Identification Number

NCT02405338

Brief Title

DC Vaccination for Post-remission Therapy in AML

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

March 2015 (Actual)

Primary Completion Date

November 2019 (Actual)

Study Completion Date

November 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medigene AG

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia

Keywords

AML

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

WT1/PRAME vaccination

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

WT1/PRAME vaccination

Primary Outcome Measure Information:

Title

Percentage of patients in whom treatment with the scheduled number of immunotherapies is feasible

Time Frame

2 years

Title

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 Measure Information:

Title

Overall survival

Time Frame

2 years

Title

Relapse/Progression free survival

Time Frame

2 years

Title

Time to progression (TTP).

Time Frame

2 years

Title

Control of minimal residual disease (MRD)

Time Frame

2 years

Title

ECOG performance status

Time Frame

2 years

Title

Cellular immune responses to applied antigens

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yngvar Fløisand

Organizational Affiliation

Oslo University Hospital, Rikshospitalet Department of Hematology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oslo University Hospital, Rikshospitalet

City

Oslo

ZIP/Postal Code

0424

Country

Norway

12. IPD Sharing Statement

Learn more about this trial

DC Vaccination for Post-remission Therapy in AML

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