Leukemic Dendritic Cell Vaccination in Patients With Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia (AML); Leukemic Dendritic Cell Vaccination
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an open label phase 1 feasibility and safety dose escalation study. The main
      objective is to evaluate the safety of DCP-001 intradermal vaccination in patients with AML.
    

Detailed description: 
      DCPrime is testing an allogeneic (non-self cells, standardised product) DC-based
      immunotherapy in cancer patients. The technology consists of sustainable dendritic progenitor
      cells (named "DCOne™") and a proprietary method to expand these and to create functional
      mature dendritic cells (DCP-001).

      AML is a fast growing form of leukemia that particularly in the elderly (>60) is life
      threatening. As age is an important factor in determining the success of AML treatment,
      overall, AML has a bad prognosis as only 24% of the patients are alive 5 years after
      diagnosis.

      Without treatment AML is fatal, usually within months. Chemotherapy can cure patients and
      prolong survival in responders; however, chemotherapy is also quite toxic and can cause
      substantial morbidity and mortality. The most commonly prescribed first line therapy for
      patients with AML is a combination of an anthracycline and cytarabine; in the Western world
      the anthracycline is either daunorubicin or idarubicin. Post remission therapy (consolidation
      therapy) is usually given.

      There is therefore substantial medical need for new treatment modalities. One of the major
      difficulties regarding development of new agents is that relatively low response rates and
      toxicity issues have been in the way of approval of new agents. Immunotherapy, in particular
      with the therapeutic vaccines, is expected to have potential in prevention of recurrence of
      disease after cytoreductive therapy. Any drug that could prevent or reduce minimal residual
      disease in the population is likely to meet a strong medical need for this population of high
      risk patients.

      In this phase 1 trial consecutive eligible patients will be treated until 12 patients have
      completed the study. Patients will be started with the vaccination program within 2 months
      after having achieved complete remission or in patients who have stable disease over at least
      a 2 month period.

      The first cohort (n=3) will receive 4 bi-weekly vaccinations of 1x10E7 DCP-001, the second
      cohort (n=3) will receive 4 bi-weekly vaccinations of 2.5x10E7 DCP-001, and the last cohort
      (n=3) will receive 4 bi-weekly vaccinations of 5x10E7 DCP-001. The Dose Limiting Toxicity
      (DTL) is defined as non-hematological toxicity of ≥ 3 according to common toxicity criteria
      v3.0. The 4th cohort (matched for HLA-A2) will receive 4 vaccinations of the highest dose
      (5x10E7 DCP-001) or, in case this turned out to be toxic (as determined by the vaccination
      profile of cohort 1, 2 and 3), this group will receive the Maximum Tolerated Dose (MTD).

      DCP-001 vaccine is presented as a direct injectable sterile cell suspension consisting of
      irradiated mature dendritic cells in cryopreservation solution packed in vials. The vaccine
      will be administered intradermally.
    

Intervention name(s): DCP-001
Intervention type(s): Biological
Intervention description(s): 4 bi-weekly vaccinations
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: DCOne; DCP-001; Second complete remission of AML; Relapse AML