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

Myelodysplastic Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00422890
• Other study ID #: TUD-RELAZA-008
• Secondary ID: 2006-001040-31 (
• Status: Completed
• Phase: Phase 3
• First received: January 15, 2007
• Last updated: July 8, 2011
• Start date: January 2007

Study information

• Verified date: July 2011
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia, Myeloid
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Myeloid Leukemia
• Preleukemia

Intervention

Drug:
• 5-Azacytidin
in case of decreasing CD34 chimerism

Locations

Country	Name	City	State
Germany	University hospital Dresden, department of medicine	Dresden	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes