NCT01734304

Brief Summary

The aim of this study is to determine the feasibility and safety of an autologous DC immunotherapy in patients with AML of non-favorable risk profile.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2013

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
11 months until next milestone

Study Start

First participant enrolled

November 5, 2013

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

4.4 years

First QC Date

October 17, 2012

Last Update Submit

October 10, 2018

Conditions

Acute Myeloid Leukemia

Keywords

vaccinationpostremission therapyacute myeloid leukemiadendritic cells

Outcome Measures

Primary Outcomes (1)

  • % of grade I/II and grade III/IV toxicities

    30 weeks

Secondary Outcomes (4)

  • Immune responses to applied antigens

    30 weeks

  • Control of minimal residual disease

    30 weeks

  • Time to progression of disease

    30 weeks

  • ECOG performance status

    30 weeks

Study Arms (1)

DC vaccination

EXPERIMENTAL

Vaccination with TLR7/8-matured DCs electroporated with mRNA encoding WT1, PRAME, and CMVpp65

Biological: DC vaccination for postremission therapy in AML

Interventions

DC vaccination for postremission therapy in AMLBIOLOGICAL

Vaccination with TLR7/8-matured DCs electroporated with mRNA encoding WT1, PRAME, and CMVpp65

DC vaccination

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients male or female, age ≥ 18 years, biological age ≤ 75 years
  • Patients with AML of non-favorable risk profile or with AML and sole NPM1 mutation and confirmed increase of MRD load as detected by RQ-PCR (in two measurements at least four weeks apart)
  • CR or CRi after intensive induction chemotherapy (TAD, HAM, sHAM, 3+7 anthracycline + cytarabine regimen, or equivalent)
  • Negative HIV test, negative hepatitis B and C test
  • Negative pregnancy test in women of childbearing potential
  • Ability to understand and willingness to sign a written informed consent

You may not qualify if:

  • Patients suitable for allogeneic HSCT (indication for allogeneic HSCT, adequate donor, no contraindication for allogeneic HSCT)
  • Patients with AML with favorable risk profile:
  • APL (AML M3)
  • inv(16), t(16;16), or del(16) as sole anomaly
  • t(8;21) as sole anomaly
  • biallelic CEBPA mutation as sole anomaly
  • NPM1 mutation as sole anomaly, unless with confirmed increase of MRD load
  • Prior allogeneic HSCT
  • Anemia (Hb \< 9,0 mg/dl)
  • Leukopenia (\< 4,0 G/l)
  • Transfusion refractory thrombocytopenia (\< 30 G/l platelets despite adequate number of transfusions)
  • Active clinically relevant autoimmune disease
  • Active immunodeficiency syndromes
  • Known allergy to GM-CSF, TNF, IFN-γ, IL-4, IL-1 beta, PGE2, R848, Human AB Serum, DMSO, HSA
  • Continuous therapy with corticosteroids or other immunosuppressive drugs during the trial
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of the University of Munich, LMU; Department od Medicine III

Munich, 81377, Germany

Location

Related Publications (1)

  • Lichtenegger FS, Schnorfeil FM, Rothe M, Deiser K, Altmann T, Bucklein VL, Kohnke T, Augsberger C, Konstandin NP, Spiekermann K, Moosmann A, Boehm S, Boxberg M, Heemskerk MH, Goerlich D, Wittmann G, Wagner B, Hiddemann W, Schendel DJ, Kvalheim G, Bigalke I, Subklewe M. Toll-like receptor 7/8-matured RNA-transduced dendritic cells as post-remission therapy in acute myeloid leukaemia: results of a phase I trial. Clin Transl Immunology. 2020 Mar 3;9(3):e1117. doi: 10.1002/cti2.1117. eCollection 2020.

    PMID: 32153780DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Marion Subklewe, PD Dr

    Department of Medicine III; Hospital of the University of Munich,

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Marion Subklewe

Study Record Dates

First Submitted

October 17, 2012

First Posted

November 27, 2012

Study Start

November 5, 2013

Primary Completion

March 31, 2018

Study Completion

September 30, 2018

Last Updated

October 12, 2018

Record last verified: 2018-10

Locations

DE(1)