European Leukemia Trial Registry
Trial: MDS 5-azacitidine (Vidaza)

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Scientific Title Treatment of imminent haematological relapse in patients with AML and MDS following allogeneic stem cell transplantation with 5-azacitidine (Vidaza®)
Short Title MDS 5-azacitidine (Vidaza)
Id KN/ELN LN_NN_2006_214
Trialgroup NN
Type of Trial prospective, open-label, pilot study
Phase Phase II
Disease Stem cell transplantation(SCT) AML
Acute myeloid leukemia(AML) Stem cell transplantation
Stem cell transplantation(SCT) MDS
Myelodysplastic Syndrome(MDS) Stem cell transplantation
Stage of Disease relapsed/refractory
Category stem cell transplantation
Aim
  • Investigation of the efficacy of 5-azacitidine in preventing haematological relapse in patients with CD34+ AML or MDS and decreasing CD34 chimerism following allogeneic HSCT
  • Investigation of the efficacy of 5-azacitidine over a follow-up period of 6 months after the last cycle
  • Investigation of the tolerability of 5-azacitidine post-allogeneic HSCT (visit 2.1 to visit 3)
Inclusion Criteria
  • Age > 18 years
  • Patients with CD34+ AML or MDS post-allogeneic HSCT
  • Written patient consent after consultation
  • Leukocytes > 3 Gpt/l and platelets > 75 Gpt/l (transfusion-independent)
  • AML/MDS: donor chimerism less than 80% in the CD34+ subpopulation following allogeneic HSCT in patients with CD34+ AML or MDS, but with no haematological relapse (blasts less than 5% in bone marrow)
Exclusion Criteria
  • Known intolerance to 5-azacitidine or mannitol
  • Uncontrollable infectious disease
  • Patients with active hepatitis B or C or HIV infection
  • Severe hepatic function impairment (ASAT and ALAT may not be above three times the normal value) or hepatic cirrhosis, or malignant hepatic tumour
  • Renal function impairment (creatinine greater than twice the normal value, creatinine clearance less than 50 ml/min)
  • Pregnancy or lactation
  • Women of childbearing age, except for those who meet the following criteria:
  • postmenopausal (12 months natural amenorrhoea)
  • postoperative (6 weeks after bilateral ovarectomy with or without hysterectomy)
  • regular and correct use of a contraceptive method with an error rate less than 1% per year (e.g. implants, depot injections, combined oral contraceptives, intrauterine device – IUD, whereby hormonal coils with a Pearl Index of less than 1% are safer than copper coils)
  • sexual abstinence
  • Partner vasectomy
  • Men who do not use one of the following for contraception:
  • sexual abstinence
  • post vasectomy
  • condoms
  • Participation of the patient in a drug trial outside the indication of allogeneic transplantation up to four weeks before study initiation
  • Addictive or other illnesses that prevent the person concerned from comprehending the nature and impact, as well as potentical consequences of the clinical trial
  • Evidence that the patient may intentionally not comply with the protocol, e.g. lack of cooperation
Age >= 18 years
Status Closed
Start of Recruitment 19.10.2006
Recruiting Countries Germany
Leader Platzbecker, Prof. Dr. med., Uwe
Scientific Contact Platzbecker, Prof. Dr. med., Uwe (Affliliation)
Contact Person

Study Physician
Weller, Dr. med., Denise
Tel: +49 (0)351 458 5134
Fax: +49 (0)351 458 5799
Email: Denise.Weller@uniklinikum-dresden.de

Biometrics
Schwanebeck, Uta
Tel: +49 (0)351 458 5134
Email: uta.schwanebeck@kksdresden.de

Centre of Trial Universitätsklinikum Carl Gustav Carus, Dresden
Shortprotocol Shortprotocol
Other Registers ClinicalTrials.gov NCT00422890 (primary Register)
European Clinical Trials Database - EUDRACT 2006-001040-31
Outcomes
  • Rise in CD34 chimerism > 80% 3 months after the last of 4 cycles of 5-azacitidine (Primary Outcome)
  • Rise in CD34 chimerism > 80% 6 months after the final cycle
  • name Incidence of infectious complications or toxicity during therapy with 5-azacitidine: allergy, hepatic toxicity (ASAT, bilirubin), renal toxicity creatinine), acute gastrointestinal toxicity (nausea, diarrhoea) and haematological toxicity (leukopenia, anaemia, thrombopenia) (visit 2.1 to visit 3)
Remark Inclusion only for patients with CD34 pos. AML or MDS
created 05.03.2007 Deniz Gökbuget
changed 05.11.2014 Alexandra Lucaciu
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