Treatment of Imminent Haematological Relapse in Patients With AML and MDS Following Allogeneic Stem Cell Transplantation With 5-azacitidine (Vidaza®)

Study Overview
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Brief Summary
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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 hematopoietic stem cell transplantation.

Conditions
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Myeloid Leukemia, Myelodysplastic Syndrome

Intervention / Treatment
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* Drug: 5-Azacytidin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 > 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 5-Azacytidin|in case of decreasing CD34 chimerism|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy 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 hematopoietic stem cell transplantation. |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 hematopoietic stem cell transplantation. |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute myeloid leukaemia or Myelodysplastic syndrome