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Acute Myeloid LeukemiaPhase 1/2NCT01734304

DC Vaccination for Postremission Therapy in AML

A Phase 1/2 study testing DC vaccination for postremission therapy in AML in people with Acute Myeloid Leukemia, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
DC vaccination for postremission therapy in AML
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteGermany
Study dates
5 Nov 2013to 30 Sep 2018
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 27Show fewer
  • 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
  • Present substance abuse or any other factor that could limit the subject's ability to comply with study procedures
  • Severe organ dysfunction:
  • Creatinine > 2,5 mg/ml
  • Bilirubin > 3,0 mg/ml
  • 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
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
  • Simultaneous participation in another clinical trial or participation in any clinical trial involving an investigational medicinal product within 30 days prior to written informed consent for this trial
  • Exclusion criteria regarding special restrictions for females:
  • Current or planned pregnancy or nursing women
  • Females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration and at least 3 months thereafter (such as oral, injectable, or im-plantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized/hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases

Trial locations and contacts

1 site in 1 country.

Germany1 site

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

    Munich, 81377

Other trials in Germany

About this study

Official title: Active Immunotherapy of Patients With Acute Myeloid Leukemia Using Autologous Dendritic Cells Transfected With RNA Encoding Leukemia-associated Antigens

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.

Read the detailed description

Patients ≥ 18 years of either gender with AML of non-favorable risk profile in CR or CRi not being eligible for allogeneic stem cell transplantation will receive as intradermal injections at two different sites up to ten immunotherapies with autologous DCs presenting two leukemia-associated antigens and one CMV antigen conserved in cryomedium over a time span of 26 weeks. Phase I will test the safety and toxicity in a small group of patients (n=6). After at least four vaccinations of three patients, the safety and toxicity data will be presented to the Data safety monitoring board (DSMB). Only after the DSMB has no objectives against the continuation of the trial, further patients will be included into the trial. Again, after three more patients, receiving a minimum of four vaccines, clinical data will be presented to the DSMB, and phase I will be terminated. The decision for continuation of the trial will be done by the DSMB. If there are no objectives by the DSMB, the trial will continue and evaluation will be started in a larger group of patients (n=14). During the phase II trial, safety and toxicity will be evaluated in a larger co-hort of patients). Besides, preliminary assessment of efficacy will be performed including induction of immunological responses to leukemia associated antigens as well as to a viral antigen (CMV), MRD control, time to progression of disease and ECOG performance status.

Being tested
DC vaccination for postremission therapy in AML
Keywords
vaccination, postremission therapy, acute myeloid leukemia, dendritic cells
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DC vaccination for postremission therapy in AMLBiological

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

Study groups in NCT01734304
Study groupRoleWhat they receive
DC vaccinationExperimentalVaccination with TLR7/8-matured DCs electroporated with mRNA encoding WT1, PRAME, and CMVpp65
Receives: Biological: DC vaccination for postremission therapy in AML

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. % of grade I/II and grade III/IV toxicities

    Measured: 30 weeks

Secondary outcomes (4)

  1. Immune responses to applied antigens

    Measured: 30 weeks

  2. Control of minimal residual disease

    Measured: 30 weeks

  3. Time to progression of disease

    Measured: 30 weeks

  4. ECOG performance status

    Measured: 30 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2012 (estimated)
  2. Study start5 Nov 2013
  3. Primary completion31 Mar 2018
  4. Study completion30 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01734304
Sponsor's protocol ID
2010-022446-24
Status last verified
Oct 2018
First submitted
17 Oct 2012
Last updated
12 Oct 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32153780

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DC vaccination for postremission therapy in AML in people with Acute Myeloid Leukemia, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

% of grade I/II and grade III/IV toxicities (time frame: 30 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01734304, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.

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