Assessment of efficacy of azacitidine to prevent a relapse
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Full eligibility criteria for NCT01462578
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
signed informed consent
Age ≥18 years
patients with MDS or AML after conventional chemotherapy or allogeneic HSCT and positive molecular marker such as t(6,9), NPM1 pos. or CD34+ or CD117+ in the case of an allogeneic HSCT Treatment:
MDS or AML without haematological relapse (blasts <5% in the bone marrow), and
decrease of CD34 donor chimerism (<80%) after allogeneic related or unrelated HSCT in CD34+ or CD117+ MDS or AML or
increase in the AML-specific molecular marker in the quantitative PCR for t(6,9), NPM1+ AML >1% after conventional chemotherapy or allogeneic HSCT or
persistence of the (above) MRD levels >1% (relative to the reference gene) after conventional chemotherapy or allogeneic HSCT
leukocytes > 3 Gpt/l and platelets >75 Gpt/l (transfusion independent)
Known history of hypersensitivity to any of the drugs used or their constituents or to drugs with similar chemical structure,
Participation of the patient in another clinical trial within the last 4 weeks before the inclusion
addiction or other disorders that do not allow the concerned person, to assess the nature and scope and possible consequences in the clinical investigation
pregnant or breast feeding women
women of childbearing potential, except women who meet the following criteria:
post-menopausal (12 months natural amenorrhea or 6 months amenorrhea with serum FSH >40 U/ml)
postoperative (6 weeks after hysterectomy with or without bilateral ovariectomy )
regular and proper use of a contraceptive method with error rate <1% per year
(e.g., implants, depot injections, oral contraceptives, intrauterine device, IUD) during study treatment and up to 1 year after completion of therapy
sexual abstinence during study treatment and up to 1 year after completion of therapy
Vasectomy of the partner
Men who do not use one of the following types of effective contraception during study treatment and up to 1 year after completion of therapy:
Evidence that the participating person is not expected to comply with the protocol
(such as lack of cooperation)
Uncontrolled active infection
Severe hepatic impairment (AST and ALT may not exceed three times the normal) or liver cirrhosis or malignant liver tumor
Dialysis dependent renal dysfunction
Known severe congestive heart failure, incidence of clinically unstable cardiac or pulmonary disease These criteria are not for the screening phase up to a known allergic reaction to azacitidine or intolerance to apply.
All locations for NCT01462578
Charité Campus Benjamin Franklin
Klinikum Chemnitz (Küchwald)
Frankfurt am Main, Germany
Universitätsklinikum Heidelberg, Medizinische Klinik, Abt. Innere Medizin V
Klinikum rechts der Isar der TU München, III. Med. Klinik und Poliklinik
View full eligibility
Tris trial is registered with FDA with number: NCT01462578. The sponsor of the trial is Technische Universität Dresden and it is looking for 93 volunteers for the current phase.
Official trial title: Treatment of Patients With MDS or AML With an Impending Hematological Relapse With Azacitidine (Vidaza)
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