Treatment of the haematological relapse in patients suffering from acute myeloid leukaemia or myelodysplastic syndrome with 5-Azacytidin (Vidaza®) after hematopoietic stem cell transplantation RELAZA - RELAZA
- Conditions
- Patients suffering from acute myeloid leukaemia or myelodysplastic syndrome with falling CD34-chimerism or relapse after hematopoietic stem cell transplantation.
- Registration Number
- EUCTR2006-001040-31-DE
- Lead Sponsor
- niversity of Technology Dresden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- Age > 18 years
- Patients with CD34+ acute myeloid leukaemia or myelodysplastic syndrome after hematopoietic stem cell transplantation
- Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Known or current abuse of drugs, medications or alcohol
- Subjects unlikely to comply with the requirements of the protocol
- Pregnancy or lactation
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy or are using a highly effective method of birth control (defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner
- Participation in another clinical trial within the last four weeks
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method