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Efficacy of Dendritic Cell Therapy for Myeloid Leukemia and Myeloma

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT00965224
First received: August 24, 2009
Last updated: July 11, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Acute Myeloid Leukemia
Chronic Myeloid Leukemia
Multiple Myeloma
Biological: dendritic cell vaccination (active specific immunotherapy)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • Immunogenicity of WT1 mRNA-transfected DC vaccination [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to relapse (TTR) [ Designated as safety issue: No ]
  • progression-free survival [ Designated as safety issue: No ]
  • overall survival (OS) [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2010
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: standard therapy + vaccination Biological: dendritic cell vaccination (active specific immunotherapy)
No Intervention: standard therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)
    • 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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965224

Locations
Belgium
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00965224     History of Changes
Other Study ID Numbers: CCRG 09-003
Study First Received: August 24, 2009
Last Updated: July 11, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Antwerp:
AML (acute myeloid leukemia)
CML (chronic myeloid leukemia)
MM (multiple myeloma)

Additional relevant MeSH terms:
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Bone Marrow Diseases
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014