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

Technische Universität Dresden

Status and phase

Completed

Phase 3

Conditions

Myelodysplastic Syndrome

Myeloid Leukemia

Treatments

Drug: 5-Azacytidin

Study type

Interventional

Funder types

Other

Identifiers

NCT00422890

TUD-RELAZA-008

2006-001040-31 (EudraCT Nr.)

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.