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Acute Myeloid LeukemiaPhase 2NCT00965224

Efficacy of Dendritic Cell Therapy for Myeloid Leukemia and Myeloma

A Phase 2 study testing dendritic cell vaccination (active specific immunotherapy) in people with Acute Myeloid Leukemia and Chronic Myeloid Leukemia, run by Zwi Berneman at 1 site in Belgium.

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

Dendritic cell therapy is a promising strategy for adjuvant cancer therapy in the setting of minimal residual disease (MRD) to fight off cancer relapse and/or progression. The investigators already performed a phase I safety study in leukemia patients that were in complete remission demonstrating the absence of side… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
dendritic cell vaccination (active specific immunotherapy)
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteBelgium
Study dates
Jan 2010to 7 Mar 2019
Phase
Phase 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Acute Myeloid Leukemia (AML): all FAB subtypes except M3. Extent of disease:
  • clinical remission after at least one course of polychemotherapy
  • high risk of relapse due to age (> 60 years) or poor risk cytogenetic/molecular markers or hyperleukocytosis at presentation or previous relapse
  • Chronic myeloid leukemia (CML): patients in chronic phase under therapy with tyrosinase kinase inhibitors who have sub-optimal response or failure and who are not eligible for hematopoietic stem cell transplantation.
  • Multiple Myeloma (MM): symptomatic with active disease, independent of earlier and/or concomitant treatment:
  • Presence of serum/urine M protein (> 3 g/dl)
Show all 18Show fewer
  • Bone marrow plasmacytosis (>10-30%)
  • Anemia, renal failure, hypercalcemia, and/or lytic bone lesions
  • Overexpression of WT1 RNA in peripheral blood and or bone marrow as assessed by quantitative RT-PCR at the time of presentation.For CML: residual molecular disease as demonstrated by BCR-ABL RT-PCR
  • Prior treatments: Patients must have received at least one prior antileukemic chemotherapeutic regimen and must be more than 1 month past the last treatment.
  • Age: ≥ 18 years
  • Performance status: WHO PS grade 0-1 (Appendix B)
  • Objectively assessable parameters of life expectancy: more than 3 months
  • Prior and concomitant associated diseases allowed with the exception of underlying autoimmune disease and positive serology for HIV/HBV/HCV
  • No concomitant use of immunosuppressive drugs
  • adequate renal and liver function, i.e. creatinin and bilirubin = 1.2 times the upper limit of normal
  • absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
  • Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation

Who cannot join

  • Subjects with concurrent additional malignancy (with exception of non-melanoma skin cancers and carcinoma in situ of the cervix)
  • Subjects who are pregnant
  • Subjects who have sensitivity to drugs that provide local anesthesia
  • Subjects needing corticosteroids 1 mg/kg during vaccination; corticosteroids are allowed as part of their treatment when taken ≥ 30 days before the start of vaccination.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • University Hospital Antwerp

    Edegem, Antwerp, 2650

Other trials in Belgium

About this study

Official title: Therapeutic Efficacy of Wilms Tumor Gene (WT1) MRNA-electroporated Autologous Dendritic Cell Vaccination in Patients with Myeloid Malignancies and Multiple Myeloma: a Phase II Trial

Dendritic cell therapy is a promising strategy for adjuvant cancer therapy in the setting of minimal residual disease (MRD) to fight off cancer relapse and/or progression. The investigators already performed a phase I safety study in leukemia patients that were in complete remission demonstrating the absence of side effects and feasibility of the therapy. Here, the investigators want to extend on this strategy by studying the clinical efficacy of autologous DC vaccination in patients with acute and chronic myeloid leukemia and myeloma patients. Effects of DC therapy on the immune reactivity towards leukemia cells as well as clinical parameters such molecular MRD monitoring, time to relapse (TTR), progression-free survival (PFS) and overall survival(OS) will be studied in vaccinated and non-vaccinated (control) patients. Patients will be vaccinated using their own dendritic cells electroporated with mRNA coding for the full-length Wilms' tumor antigen WT1.

Being tested
dendritic cell vaccination (active specific immunotherapy)
Keywords
AML (acute myeloid leukemia), CML (chronic myeloid leukemia), MM (multiple myeloma)
Medical subject headings
Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Multiple Myeloma

What participants receive

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

  • dendritic cell vaccination (active specific immunotherapy)Biological

Study groups in NCT00965224
Study groupRoleWhat they receive
standard therapy + vaccinationExperimentalNot described
Receives: Biological: dendritic cell vaccination (active specific immunotherapy)

What is being measured

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

  1. Immunogenicity of WT1 mRNA-transfected DC vaccination

    Measured: Upon completion of blood sample collection (before start of the vaccination at week 0 and 8 weeks after start of the vaccination) and skin biopsy collection (8 weeks after start of the vaccination) for all included patients

  2. Induction/maintenance of molecular remission as evidenced by molecular MRD monitoring of WT1 (AML, CML and MM) and BCR/ABL RNA (CML) copies in peripheral blood

    Measured: Upon follow-up completion for all included patients, i.e. until 24 months after the last vaccination

Secondary outcomes (3)

  1. Time to relapse (TTR)

    Measured: Upon follow-up completion for all included patients, i.e. until 24 months after the last vaccination

  2. progression-free survival

    Measured: Upon follow-up completion for all included patients, i.e. until 24 months after the last vaccination

  3. overall survival (OS)

    Measured: Upon follow-up completion for all included patients, i.e. until 24 months after the last vaccination

Timeline

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

  1. First posted25 Aug 2009 (estimated)
  2. Study startJan 2010
  3. Primary completionDec 2014
  4. Study completion7 Mar 2019

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00965224
Sponsor's protocol ID
CCRG 09-003
Status last verified
Dec 2024
First submitted
24 Aug 2009
Last updated
13 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Van Driessche A, Van de Velde AL, Nijs G, Braeckman T, Stein B, De Vries JM, Berneman ZN, Van Tendeloo VF. Clinical-grade manufacturing of autologous mature mRNA-electroporated dendritic cells and safety testing in acute myeloid leukemia patients in a phase I dose-escalation clinical trial. Cytotherapy. 2009;11(5):653-68. doi: 10.1080/14653240902960411.

    PubMed 19530029

  • Smits EL, Berneman ZN, Van Tendeloo VF. Immunotherapy of acute myeloid leukemia: current approaches. Oncologist. 2009 Mar;14(3):240-52. doi: 10.1634/theoncologist.2008-0165. Epub 2009 Mar 16.

    PubMed 19289488

  • Van Driessche A, Gao L, Stauss HJ, Ponsaerts P, Van Bockstaele DR, Berneman ZN, Van Tendeloo VF. Antigen-specific cellular immunotherapy of leukemia. Leukemia. 2005 Nov;19(11):1863-71. doi: 10.1038/sj.leu.2403930.

    PubMed 16121214

  • Smits EL, Anguille S, Cools N, Berneman ZN, Van Tendeloo VF. Dendritic cell-based cancer gene therapy. Hum Gene Ther. 2009 Oct;20(10):1106-18. doi: 10.1089/hum.2009.145.

    PubMed 19656053

  • Anguille S, Van de Velde AL, Smits EL, Van Tendeloo VF, Juliusson G, Cools N, Nijs G, Stein B, Lion E, Van Driessche A, Vandenbosch I, Verlinden A, Gadisseur AP, Schroyens WA, Muylle L, Vermeulen K, Maes MB, Deiteren K, Malfait R, Gostick E, Lammens M, Couttenye MM, Jorens P, Goossens H, Price DA, Ladell K, Oka Y, Fujiki F, Oji Y, Sugiyama H, Berneman ZN. Dendritic cell vaccination as postremission treatment to prevent or delay relapse in acute myeloid leukemia. Blood. 2017 Oct 12;130(15):1713-1721. doi: 10.1182/blood-2017-04-780155. Epub 2017 Aug 22.

    PubMed 28830889

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing dendritic cell vaccination (active specific immunotherapy) in people with Acute Myeloid Leukemia and Chronic Myeloid Leukemia, run by Zwi Berneman at 1 site in Belgium.

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 18 inclusion and 4 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 13 Dec 2024. 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 Belgium. 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 phase mean?

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?

Immunogenicity of WT1 mRNA-transfected DC vaccination (time frame: Upon completion of blood sample collection (before start of the vaccination at week 0 and 8 weeks after start of the vaccination) and skin biopsy collection (8 weeks after start of the vaccination) for all included patients). The study lists 2 primary outcomes in all. 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 NCT00965224, which also lists 5 linked publications.

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 13 Dec 2024.

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