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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


Phase 2
18 Years
N/A
Open (Enrolling by invite only)
Both
Acute Myeloid Leukemia, Chronic Myeloid Leukemia, Multiple Myeloma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Outcome Measure:

Immunogenicity of WT1 mRNA-transfected DC vaccination

Safety Issue:

No

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

CCRG 09-003

NCT ID:

NCT00965224

Start Date:

January 2010

Completion Date:

Related Keywords:

  • Acute Myeloid Leukemia
  • Chronic Myeloid Leukemia
  • Multiple Myeloma
  • AML (acute myeloid leukemia)
  • CML (chronic myeloid leukemia)
  • MM (multiple myeloma)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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