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Efficacy Study of Dendritic Cell Vaccination in Patients With Acute Myeloid Leukemia in Remission (WIDEA)

Primary Purpose

Acute Myeloid Leukemia

Status
Recruiting
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
DC vaccine
Sponsored by
Zwi Berneman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring in complete remission, Adult (>18 years) at very high risk of relapse

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of acute myeloid leukemia (AML) according to the 2008 criteria of the World Health Organization (WHO).

    • all French-American-British (FAB) subtypes, except:

      - M3 (acute promyelocytic leukemia)

    • all cases of de novo AML or secondary AML with ≥ 20 % blasts in peripheral blood and/or bone marrow, except:

      • AML secondary to myeloproliferative neoplasms (MPN)
      • AML secondary to exposure of leukemogenic agents (t-AML) unless treated with CPX-351 chemotherapy or hypomethylating agents combined with venetoclax.
  • Completion of one of the following treatment options:

    • I) Intensive chemotherapy:

      • (1) at least one cycle of induction chemotherapy and one cycle of consolidation chemotherapy (low-dose cytarabine as consolidation therapy is allowed) OR
      • (2) one to two cycles of CPX-351 induction treatment and up to two cycles of CPX-351 consolidation treatment OR
    • II) Low-intensity chemotherapy:

      • (3) at least two cycles to maximum six cycles of hypomethylating agents whether or not combined with venetoclax OR
      • (4) at least two cycles to maximum six cycles of low-dose cytarabine combined with venetoclax;
    • resulting in:

      • morphological complete remission (CR), i.e. bone marrow blast count <5% with neutrophil count >1000 cells/µL and platelet count >100,000 cells/µL OR
      • morphological complete remission with incomplete blood recovery (CRi), i.e. bone marrow blast count <5% with neutrophil count <1000 cells/µL or platelet count <100,000 cells/µL.

For the purpose of this study protocol, platelet count must be >50,000 cells/µL.

  • Interval between the completion of the last intensive chemotherapy administration (in case of low-intensity chemotherapy: last cycle (min. 2 to max. 6 cycles) before achieving CR or CRi) and the start of vaccination (or the start of follow-up in case of the control arm): 6 weeks (minimum) and 16 weeks (maximum) (in case of low-intensity chemotherapy: maximum 10 weeks).
  • Adult (≥ 18 years) at very high risk of relapse according to:

    • Age ≥ 60 years, and/or
    • Adverse biological features (e.g. adverse cytogenetics, adverse morphological features, adverse molecular features, hyperleukocytosis (> 100000 cells/µL)), and
    • Ineligible for or unwilling to receive hematopoietic stem cell transplantation.
  • WHO performance status: grade 0, 1 or 2 at the time of enrollment. For definition of performance status, see: http://www.ecog.org/general/perf_stat.html
  • Absence of any psychological, familial, sociological, geographical or physical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before study entry.

Exclusion Criteria:

  • Participation in any other interventional clinical trial during the study period.
  • History or concomitant presence of any other malignancy, except for:

    • non-melanoma skin cancer
    • carcinoma in situ of the cervix
    • any other effectively treated malignancy that has been in remission for >5 years or that is highly likely to be cured at the time of enrollment.
  • Concomitant presence of any immunosuppressive disease (e.g. HIV) or any active autoimmune condition, except for vitiligo.
  • Concomitant use of systemic corticosteroids in immunosuppressive doses (>1 mg/kg/day of prednisone, or equivalent dose for other corticosteroid preparations) or any other immunosuppressive agent. A minimum of 4 weeks must have elapsed between the last dose of immunosuppressive therapy and the first vaccination. Topical corticosteroids are permitted, except if applied at the sites of DC injection.
  • Pregnant or breast-feeding

Sites / Locations

  • ZNA StuivenbergRecruiting
  • Antwerp University HospitalRecruiting
  • University Hospital BrusselsRecruiting
  • Cliniques Universitaires Saint-LucRecruiting
  • Ghent University HospitalRecruiting
  • Centre Hospitalier Universitaire de LiègeRecruiting
  • AZ DeltaRecruiting
  • CHU Mont GodinneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

DC vaccine

Control arm

Arm Description

Vaccination with autologous WT1 mRNA-electroporated DCs plus follow-up care. Patients receiving low-intensity chemotherapy are allowed to continue this treatment in combination with DC vaccination.

Follow-up care. Patients receiving low-intensity chemotherapy are allowed to continue this treatment during the follow-up care

Outcomes

Primary Outcome Measures

Overall survival
The primary objective of this randomized phase II clinical study is to determine the effect of WT1-targeted dendritic cell vaccination on overall survival in adult AML patients at very high risk of relapse and in complete remission.

Secondary Outcome Measures

Relapse rate
to determine the effect of WT1-targeted dendritic cell vaccination on relapse rate in adult AML patients at very high risk of relapse and in complete remission.
relapse-free survival
to determine the effect of WT1-targeted dendritic cell vaccination on relapse-free survival in adult AML patients at very high risk of relapse and in complete remission.
Change in WT1 mRNA levels in peripheral blood
Efficacy assessment will also be performed on a molecular level. To this end, peripheral blood samples will be obtained from participants in both study groups (vaccine group and control group) and analyzed by qRT-PCR for WT1 expression, which is a promising molecular biomarker in AML.
Immune activation
This study aims to examine the presence of leukemia-specific immune responses in AML patients in remission and to investigate whether they can be induced or increased in these patients by WT1 mRNA-electroporated DC vaccination.
General and disease-specific quality of life
Patients will be asked to fill out general and disease-specific quality of life questionnaires to assess changes in general and disease-specific quality of life during the study at regular time points

Full Information

First Posted
July 26, 2012
Last Updated
January 15, 2021
Sponsor
Zwi Berneman
Collaborators
Kom Op Tegen Kanker, Stichting tegen Kanker, Research Foundation - Flanders (FWO: Fonds Wetenschappelijk Onderzoek)
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1. Study Identification

Unique Protocol Identification Number
NCT01686334
Brief Title
Efficacy Study of Dendritic Cell Vaccination in Patients With Acute Myeloid Leukemia in Remission
Acronym
WIDEA
Official Title
Wilms' Tumor (WT1) Antigen-targeted Dendritic Cell Vaccination to Prevent Relapse in Adult Patients With Acute Myeloid Leukemia: a Multicenter Randomized Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 2012 (undefined)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zwi Berneman
Collaborators
Kom Op Tegen Kanker, Stichting tegen Kanker, Research Foundation - Flanders (FWO: Fonds Wetenschappelijk Onderzoek)

4. Oversight

5. Study Description

Brief Summary
The primary aim of this innovative immunotherapeutic study is to determine whether the antileukemic effects seen in our previous phase I/II study can be confirmed in a large cohort of patients and whether dendritic cell vaccination can significantly prevent relapse and increase survival of acute myeloid leukemia (AML) patients by eradicating minimal residual disease.
Detailed Description
Together with the Transplant Committee of the Belgian Hematological Society (BHS), we will perform a multicenter randomized open-label phase II clinical study in 130 patients with acute myeloid leukemia (AML). Adult patients (> 18 years) with AML who have entered morphological CR or CRi after (1) intensive chemotherapy (i.e (i) at least one cycle of induction and one cycle of consolidation chemotherapy or (ii) one to two cycles of CPX-351 induction treatment and up to two cycles of CPX-351 consolidation treatment) or (2) low-intensity chemotherapy (i.e (iii) at least two cycles to maximum six cycles of hypomethylating agents whether or not combined with venetoclax or (iv) at least two cycles to maximum six cycles of low-dose cytarabine combined with venetoclax); and fulfilling all other eligibility criteria will be randomized to be vaccinated with dendritic cells or to receive regular follow-up care. After randomization, patients receiving low-intensity chemotherapy are allowed to continue this treatment in combination with DC vaccination or the follow-up care. The primary aim of this innovative immunotherapeutic study is to determine whether the antileukemic effects seen in our previous phase I/II study can be confirmed in a large cohort of patients and whether dendritic cell vaccination can significantly prevent relapse and increase survival of AML patients by eradicating minimal residual disease. Patients will be recruited at 8 different centers in Belgium. Recruitment will start in the second half of 2013 and will last for 10 years or until 130 efficacy-evaluable AML patients are included. In the interventional group, 65 patients will be treated during two years with autologous dendritic cells loaded by messenger RNA electroporation with the Wilms' tumor antigen (WT1). The dendritic cell therapy product will be generated and generally administered in the coordinating center, which is the Antwerp University Hospital, more specifically the Center for Cell Therapy and Regenerative Medicine (CCRG) and the Division of Hematology, both headed by Prof. Zwi Berneman. After inclusion of 130 efficacy-evaluable patients, relapse rate, relapse-free survival and overall survival analysis will be performed. Tumor marker levels and immune activation will also be monitored to compare the 2 groups at a molecular and immunological level. General and disease-specific quality of life will be evaluated using quality of life questionnaires at regular time points.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
in complete remission, Adult (>18 years) at very high risk of relapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DC vaccine
Arm Type
Experimental
Arm Description
Vaccination with autologous WT1 mRNA-electroporated DCs plus follow-up care. Patients receiving low-intensity chemotherapy are allowed to continue this treatment in combination with DC vaccination.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Follow-up care. Patients receiving low-intensity chemotherapy are allowed to continue this treatment during the follow-up care
Intervention Type
Biological
Intervention Name(s)
DC vaccine
Intervention Description
Autologous WT1 mRNA-electroporated DCs
Primary Outcome Measure Information:
Title
Overall survival
Description
The primary objective of this randomized phase II clinical study is to determine the effect of WT1-targeted dendritic cell vaccination on overall survival in adult AML patients at very high risk of relapse and in complete remission.
Time Frame
At study completion, an average of 5 year
Secondary Outcome Measure Information:
Title
Relapse rate
Description
to determine the effect of WT1-targeted dendritic cell vaccination on relapse rate in adult AML patients at very high risk of relapse and in complete remission.
Time Frame
At study completion, an average of 5 year
Title
relapse-free survival
Description
to determine the effect of WT1-targeted dendritic cell vaccination on relapse-free survival in adult AML patients at very high risk of relapse and in complete remission.
Time Frame
At study completion, an average of 5 year
Title
Change in WT1 mRNA levels in peripheral blood
Description
Efficacy assessment will also be performed on a molecular level. To this end, peripheral blood samples will be obtained from participants in both study groups (vaccine group and control group) and analyzed by qRT-PCR for WT1 expression, which is a promising molecular biomarker in AML.
Time Frame
Through study completion, at every vaccination during 2 years
Title
Immune activation
Description
This study aims to examine the presence of leukemia-specific immune responses in AML patients in remission and to investigate whether they can be induced or increased in these patients by WT1 mRNA-electroporated DC vaccination.
Time Frame
After the 4th DC vaccine
Title
General and disease-specific quality of life
Description
Patients will be asked to fill out general and disease-specific quality of life questionnaires to assess changes in general and disease-specific quality of life during the study at regular time points
Time Frame
At study completion, an average of 5 year
Other Pre-specified Outcome Measures:
Title
Tertiary: Safety
Description
To corroborate the safety of WT1 mRNA-electroporated DC vaccination in adult patients with AML. Safety will be assessed at every visit by adverse event reporting and clinical laboratory tests.
Time Frame
At study completion, an average of 5 year
Title
Exploratory: Effect of low-intensity chemotherapy
Description
To evaluate the effect of low-intensity chemotherapy on the primary and secondary objectives.
Time Frame
At study completion, an average of 5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of acute myeloid leukemia (AML) according to the 2008 criteria of the World Health Organization (WHO). all French-American-British (FAB) subtypes, except: - M3 (acute promyelocytic leukemia) all cases of de novo AML or secondary AML with ≥ 20 % blasts in peripheral blood and/or bone marrow, except: AML secondary to myeloproliferative neoplasms (MPN) AML secondary to exposure of leukemogenic agents (t-AML) unless treated with CPX-351 chemotherapy or hypomethylating agents combined with venetoclax. Completion of one of the following treatment options: I) Intensive chemotherapy: (1) at least one cycle of induction chemotherapy and one cycle of consolidation chemotherapy (low-dose cytarabine as consolidation therapy is allowed) OR (2) one to two cycles of CPX-351 induction treatment and up to two cycles of CPX-351 consolidation treatment OR II) Low-intensity chemotherapy: (3) at least two cycles to maximum six cycles of hypomethylating agents whether or not combined with venetoclax OR (4) at least two cycles to maximum six cycles of low-dose cytarabine combined with venetoclax; resulting in: morphological complete remission (CR), i.e. bone marrow blast count <5% with neutrophil count >1000 cells/µL and platelet count >100,000 cells/µL OR morphological complete remission with incomplete blood recovery (CRi), i.e. bone marrow blast count <5% with neutrophil count <1000 cells/µL or platelet count <100,000 cells/µL. For the purpose of this study protocol, platelet count must be >50,000 cells/µL. Interval between the completion of the last intensive chemotherapy administration (in case of low-intensity chemotherapy: last cycle (min. 2 to max. 6 cycles) before achieving CR or CRi) and the start of vaccination (or the start of follow-up in case of the control arm): 6 weeks (minimum) and 16 weeks (maximum) (in case of low-intensity chemotherapy: maximum 10 weeks). Adult (≥ 18 years) at very high risk of relapse according to: Age ≥ 60 years, and/or Adverse biological features (e.g. adverse cytogenetics, adverse morphological features, adverse molecular features, hyperleukocytosis (> 100000 cells/µL)), and Ineligible for or unwilling to receive hematopoietic stem cell transplantation. WHO performance status: grade 0, 1 or 2 at the time of enrollment. For definition of performance status, see: http://www.ecog.org/general/perf_stat.html Absence of any psychological, familial, sociological, geographical or physical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before study entry. Exclusion Criteria: Participation in any other interventional clinical trial during the study period. History or concomitant presence of any other malignancy, except for: non-melanoma skin cancer carcinoma in situ of the cervix any other effectively treated malignancy that has been in remission for >5 years or that is highly likely to be cured at the time of enrollment. Concomitant presence of any immunosuppressive disease (e.g. HIV) or any active autoimmune condition, except for vitiligo. Concomitant use of systemic corticosteroids in immunosuppressive doses (>1 mg/kg/day of prednisone, or equivalent dose for other corticosteroid preparations) or any other immunosuppressive agent. A minimum of 4 weeks must have elapsed between the last dose of immunosuppressive therapy and the first vaccination. Topical corticosteroids are permitted, except if applied at the sites of DC injection. Pregnant or breast-feeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zwi N Berneman, MD, PhD
Phone
+32 3 8213780
Email
zwi.berneman@uza.be
First Name & Middle Initial & Last Name or Official Title & Degree
Ann Van de Velde, MD, PhD
Phone
+32 3 8213916
Email
ann.vandevelde@uza.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zwi Berneman, MD, PhD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Evelien LJ Smits, MSc, PhD
Organizational Affiliation
Universiteit Antwerpen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sébastien Anguille, MD, PhD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ann Van de Velde, MD, PhD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
ZNA Stuivenberg
City
Antwerp
ZIP/Postal Code
2060
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Local Investigator: Dimitri Breems, MD, PhD
Facility Name
Antwerp University Hospital
City
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zwi N Berneman, MD, PhD
Facility Name
University Hospital Brussels
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Local Investigator: Rik Schots, MD, PhD
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussel
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Local Investigator: Violaine Havelange, MD, PhD
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Local Investigator: Tessa Kerre, MD, PhD
Facility Name
Centre Hospitalier Universitaire de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Local Investigator: Yves Beguin, MD, PhD
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Local Investigator: Dries Deeren, MD
Facility Name
CHU Mont Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Local Investigator: Carlos Graux, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
20631300
Citation
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Citation
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PubMed Identifier
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Efficacy Study of Dendritic Cell Vaccination in Patients With Acute Myeloid Leukemia in Remission

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