Clinical trial NCT00422890: Treatment of Imminent Haematological Relapse in Patients With AML and MDS Following Allogeneic Stem Cell Transplantation With 5-azacitidine (Vidaza®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myeloid Leukemia
Myelodysplastic Syndrome
Keywords: Acute myeloid leukaemia or Myelodysplastic syndrome
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2007-01-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 4 months
Secondary outcomes:
measure: 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.
timeFrame: 4 months
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University hospital Dresden, department of medicine
state: Saxony
Study officials:
affiliation: Univesity Hospital Dresden, department of medicine
name: Uwe Platzbecker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Colbers A, Best B, Schalkwijk S, Wang J, Stek A, Hidalgo Tenorio C, Hawkins D, Taylor G, Kreitchmann R, Burchett S, Haberl A, Kabeya K, van Kasteren M, Smith E, Capparelli E, Burger D, Mirochnick M; PANNA Network and the IMPAACT 1026 Study Team. Maraviroc Pharmacokinetics in HIV-1-Infected Pregnant Women. Clin Infect Dis. 2015 Nov 15;61(10):1582-9. doi: 10.1093/cid/civ587. Epub 2015 Jul 22.