Status:
COMPLETED
Efficacy of Dendritic Cell Therapy for Myeloid Leukemia and Myeloma
Lead Sponsor:
Zwi Berneman
Conditions:
Acute Myeloid Leukemia
Chronic Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 pe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2019
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00965224
Start Date
January 1 2010
End Date
March 7 2019
Last Update
December 13 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650