Status:
COMPLETED
Dendritic Cell Vaccination for Patients With Acute Myeloid Leukemia in Remission
Lead Sponsor:
University Hospital, Antwerp
Conditions:
Acute Myeloid Leukemia (AML)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Vaccines made from a patient's white blood cells (dendritic cells) and a specific leukemia antigen (Wilms tumor antigen-1) may induce an effective immune response to kill residual leukemic ...
Detailed Description
Autologous dendritic cell (DC) vaccination is a promising strategy for adjuvant cancer therapy in the setting of minimal residual disease (MRD). We performed a phase I/II trial in patients with acute ...
Eligibility Criteria
Inclusion
- Tumor type: Acute Myeloid Leukemia (AML) according to the WHO criteria (ea at least 20% blasts in the marrow). All FAB subtypes except M3. Patients with Myelodysplastic Syndrome, category of Refractory Anemia with Excess Blasts (RAEB): RAEB I (WHO: medullary blast count ≤ 10% and a peripheral blast count ≤ 5%) and RAEB II (WHO: medullary blast count \> 10% and/or \> 5% peripheral blasts) can be included in the study in absence of other non-experimental treatment modalities.
- Extent of disease: remission (partial or complete) or smouldering course. Complete remission (CR) is defined as no blasts in the peripheral blood and no more than 5% blasts in the bone marrow. This definition is related to the hematological remission if it is not specified. Partial remission (PR) is defined as a decrease of at least 50% in the percentage of blasts to 5 to 25% in the bone marrow aspirate. Smouldering course is defined as a relatively low marrow blast count and slowly progressive disease.
- Overexpression of WT1 RNA (\>50 copies of WT1 per 1000 copies ABL in bone marrow or \>2 copy/1000 copies ABL in peripheral blood) as assessed by quantitative RT-PCR at the time of presentation.
- Prior treatments : Patients must have received at least one prior antileukemic chemotherapeutic regimen and must be more than 1 month past the last treatment and/or 6 months past allogeneic/autologous stem cell transplantation.
- Age: ≥ 18 years
- High risk of relapse because of (and/or)
- Age \> 60 years (if \<60 y, no sibling allotransplant donor available)
- Poor risk cytogenetic or molecular markers at presentation
- Hyperleukocytosis at presentation
- Second complete remission after relapse
- 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
- 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
- Age \< 18 years
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00834002
Start Date
March 1 2005
End Date
December 1 2008
Last Update
February 9 2010
Active Locations (1)
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1
Antwerp University Hospital/Center for Cellular Therapy and Regenerative Medicine
Edegem, Belgium, 2650