Deutsches Leukämie-Studienregister
Studie: RELAZA2

Kurzübersicht
Öffentlicher Titel Azacitidin bei drohendem hämatologischen Rezidiv
Wissenschaftl. Titel Treatment of Patients With MDS or AML With an Impending Hematological Relapse With Azacitidin (Vidaza)
Kurztitel RELAZA2
Studiennummer KN/ELN LN_SAL_2011_487
Studiengruppe SAL
Studienphase Phase II
Erkrankung Myelodysplastisches Syndrom (MDS) - Intermediär II und Hochrisiko
Akute myeloische Leukämie (AML) - AML alle außer FAB M3
Leukämiestadium molekulares Rezidiv
Molekularer Marker NPM1
Ziele
  • Analysis of the effectiveness of azacitidine 6 months after start of therapy to prevent a hematological relapse in MDS or AML patients with significant residuals or an increase of minimal residual disease (MRD) which is defined as
  • decrease of CD34 donor chimerism (<80%) after allogeneic related or unrelated HSCT in CD34+ MDS or AML or
  • increase in the AML-specific molecular markers in the quantitative PCR for t(8,21), inv16, t(6,9), NPM1+ AML >1% (ratio to reference gene) after conventional chemotherapy or allogeneic HSCT or
  • persistence of the (above) MRD level >1% after conventional chemotherapy or alloge-neic HSCT
  • tolerance of azacitidine
  • quality of the response of the MRD (major vs. minor) and the relapse-free survival and overall survival 12, 24 and 30 months after starting treatment with azacitidine
  • modulation of CD34+, NK- and T-cells of MDS and AML patients by azacitidine
Einschlusskriterien
  • Screening:
  • signed informed consent
  • Age >=18 years
  • patients with MDS or AML after conventional chemotherapy or allogeneic HSCT and positive molecular marker such as t(8,21), inv16, t(6,9), NPM1 pos. or CD34+ 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+ MDS or AML or
  • increase in the AML-specific molecular marker in the quantitative PCR for t(8;21), inv16, 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)
Ausschlusskriterien
  • 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 bilateral ovariectomy with or without hysterectomy)
  • regular and proper use of a contraceptive method with error rate < 1 % per year (e.g., implants, depot injections, oral contraceptives, intrauterine device, IUD)
  • sexual abstinence
  • Vasectomy of the partner
  • Men who do not use one of the following types of contraception for a period of 3 months after completion of therapy:
  • sexual abstinence
  • State post-vasectomy
  • Condom
  • 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.
Alter >= 18 Jahre
Status Aktiv
Beginn der Rekrutierung 28.09.2011
Rekrutierende Länder Deutschland
Studienleiter/in Platzbecker, Prof. Dr. med., Uwe
Ansprechpartner

Studienleiter
Platzbecker, Prof. Dr. med., Uwe
Tel: +49 (0)351 4582583
Fax: +49 (0)351 458-5362
E-Mail: Uwe.Platzbecker@uniklinikum-dresden.de

Studienzentrale
Lehmann, Gina
Tel: +49 (0)351 458 7172
Fax: +49 (0)351 458 4367
E-Mail: gina.lehmann@uniklinikum-dresden.de

Studienzentrale SAL-Studienzentrale, Universitätsklinikum Carl Gustav Carus, Dresden
Kurzprotokoll Kurzprotokoll
Sponsoren Technische Universität Dresden (Hauptsponsor)
Registrierung in anderen Studienregistern ClinicalTrials.gov NCT01462578 (primäres Register)
Haupt- und Nebenzielkriterien
  • Number of patients with hematological relapse 6 months after start of treatment with azacitidin 6 months after end of treatment (Hauptzielkriterium)
  • Number of occurrence or exacerbation of clinical relevant acute or chronic GvHD 2 years follow-up after treatment
  • Number of patients with infectious SAEs (rate of SAE) 2 years follow-up after treatment
  • Rate of changes of methylation in CD34+ cells 2 years follow-up after treatment
  • Relapse-free survival and overall survival 12, 24 and 30 months after start of treatment
Therapie Drug: Azacitidine injection, subcutaneous; initial minimum 6 cycles; another 6 or 12 cycles according to MRD niveau; maximum 24 cycles
Anmerkung Teilnehmende Prüfzentren: Charité Campus Benjamin Franklin, Universitätsmedizin Berlin; Universitätsklinikum Carl Gustav Carus, Medizinische Klinik und Poliklinik I, Dresden; Universitätsklinikum Essen, Klinik für Hämatologie (Westdeutsches Tumorzentrum); Universitätsklinikum Frankfurt, Medizinische Klinik II, Hämatologie/Onkologie; Klinikum rechts der Isar der, TU München; Universitätsklinikum Münster, Medizinische Klinik und Poliklinik A; Ruprecht-Karls-Universität Heidelberg, Medizinische Klinik V; Universitätsklinikum Freiburg, Klinik für Innere Medizin I; Klinikum der Universität München, Campus Großhadern; www.sal-aml.org
erstellt 24.04.2012 Luise Kloos
geändert 30.07.2018 Martina Wolkenfeld
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