European Leukemia Trial Registry
Trial: CML Dendritic cells

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Scientific Title Dendritic cells as autologous vaccine in patients with chronic myeloid leukemia
Short Title CML Dendritic cells
Id KN/ELN LN_EZIEXP_2001_96
Trialgroup EZI-Expertengruppe
Type of Trial single-group
Phase Phase I
Disease Chronic myeloid leukemia(CML) All subtypes
Stage of Disease .
Inclusion Criteria
  • Curative options (e.g. allogeneic bone marrow transplantation) should not be available or should have been refused by the patient
  • Activity index of 0-2 according to WHO index or Karnofsky index > 60
  • Life expectancy > 3 months
  • Platelet count > 50.000/μl and lymphocyte count > 1500/μl
  • Ability to respond to recall antigens (as determined by skin test reactivity) should not be compromised
  • Informed consent
  • NB: Patients treated with interferon can only enter the study, if they failed to reach a major cytogenetic response after at least 12 months of interferon
Exclusion Criteria
  • Autoimmune disorders
  • Immunodeficiency syndromes
  • Known allergy to GM-CSF, TNF-α, IL-4 or KLH (Keyhole Limpet Hemocyanin)
  • Pregnancy
  • Active infectious disease
  • Continuous therapy with corticosteroids or other immunosuppressive medications
  • Psychiatric disorders
  • Organ dysfunction, defined as follows:
  • Thrombin time/partial thromboplastin time > 1.5 UNL
  • Creatinine > 2.0 mg/ml
  • Bilirubin > 3,0 mg/ml
  • ALAT/ASAT > 5 x UNL
  • Pulmonary dysfunction (dyspnea at rest or with minimal exertion)
  • Clinically relevant coronary heart disease or ventricular arrhythmia
  • Congestive heart failure > grade II NYHA
Age All ages
Status Closed
Start of Recruitment 01.01.2001
Leader Pezzutto, Prof. Dr. med., Antonio
Contact Person

General Contact Person
Westermann, Dr. med., J.

Centre of Trial Charité Universitätsmedizin Berlin, Campus Rudolf Virchow
Shortprotocol Shortprotocol
created 26.07.2006 Anja Hellenbrecht
changed 20.03.2015 Hanna Ebert
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