Dendritic Cell Vaccination for Patients With Acute Myeloid Leukemia in Remission

NCT00834002 | Completed Phase 1

• 1 other identifier: EC 5/6/29
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 cells and/or prevent leukemia relapse. PURPOSE: This phase I/II trial is studying the feasibility, safety and efficacy of intradermal mRNA-transfected dendritic cell vaccination therapy in patients with acute myeloid leukemia.

Conditions

Acute Myeloid Leukemia (AML)

Keywords

AML in remission

Outcome Measures

Primary Outcomes (2)

• acute toxicity of intradermal injections of WT1 mRNA-electroporated autologous dendritic cells

• feasibility to generate functional DC vaccines from leukapheresis material from AML patient in remission

Secondary Outcomes (1)

• T cell immunogenicity of WT1 mRNA-loaded dendritic cell vaccines in AML patients in remission

Interventions

injection of antigen-loaded cultured dendritic cells BIOLOGICAL

intradermal injection of WT1-RNA-electroporated autologous dendritic cell vaccine (therapeutic cell vaccine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

Antwerp University Hospital/Center for Cellular Therapy and Regenerative Medicine

Edegem, 2650, Belgium

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Zwi Berneman, MD, PHD

  University Hospital, Antwerp

  STUDY DIRECTOR

• Ann Van de Velde, MD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

• Viggo FI Van Tendeloo, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 30, 2009
• First Posted: February 2, 2009
• Study Start: March 1, 2005
• Primary Completion: November 1, 2007
• Study Completion: December 1, 2008
• Last Updated: February 9, 2010

Record last verified: 2009-08

Locations

BE (1)