Efficacy of Dendritic Cell Therapy for Myeloid Leukemia and Myeloma
NCT ID: NCT00965224
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
38 participants
INTERVENTIONAL
2010-01-31
2019-03-07
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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standard therapy + vaccination
dendritic cell vaccination (active specific immunotherapy)
Interventions
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dendritic cell vaccination (active specific immunotherapy)
Eligibility Criteria
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Inclusion Criteria
* 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)
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Zwi Berneman
OTHER
Responsible Party
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Zwi Berneman
Professor Dr. Zwi Berneman
Locations
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University Hospital Antwerp
Edegem, Antwerp, Belgium
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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CCRG 09-003
Identifier Type: -
Identifier Source: org_study_id