Status:
COMPLETED
Treatment of Imminent Haematological Relapse in Patients With AML and MDS Following Allogeneic Stem Cell Transplantation With 5-azacitidine (Vidaza®)
Lead Sponsor:
Technische Universität Dresden
Conditions:
Myeloid Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Efficacy and safety of 5-Azacytidin in the treatment of the haematological relapse in patients suffering from acute myeloid leukaemia or myelodysplastic syndrome with falling CD34-chimerism after hema...
Eligibility Criteria
Inclusion
- Screening phase:
- Age \> 18 years
- Patients with CD34+ AML or MDS post-allogeneic HSCT
- Written patient consent after consultation
- Treatment phase
- AML/MDS: donor chimerism \< 80% in the CD34+ subpopulation following allogeneic HSCT in patients with CD34+ AML or MDS, but with no haematological relapse (blasts \< 5% in bone marrow)
- Leukocytes \> 3 Gpt/l and platelets \> 75 Gpt/l (transfusion-independent)
Exclusion
- 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 \> twice the normal value, creatinine clearance \< 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 \< 1% per year (e.g. implants, depot injections, combined oral contraceptives, intrauterine device - IUD, whereby hormonal coils with a Pearl Index of \< 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 With the exception of a known allergic reaction or intolerance to 5-azacitidine, these criteria do not apply to the screening phase.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00422890
Start Date
January 1 2007
Last Update
July 11 2011
Active Locations (1)
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1
University hospital Dresden, department of medicine
Dresden, Saxony, Germany, 01307