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

Phase 3

Completed

• Conditions: Myeloid Leukemia; Myelodysplastic Syndrome

• Registration Number: NCT00422890
• Lead Sponsor: Technische Universität Dresden

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 hematopoietic stem cell transplantation.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-15
• Study First Submitted QC: 2007-01-16
• Study First Posted: 2007-01-17
• Primary Completion: 2009-12
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-08
• Last Update Posted: 2011-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University hospital Dresden, department of medicine; 🇩🇪 Dresden, Saxony, Germany