Treatment of Patients With Myelodysplastic Syndrome or Acute Myelocytic Leukemia With an Impending Hematological Relapse With Azacitidine (Vidaza)
- Conditions
- Myelodysplastic SyndromeAcute Myelocytic Leukemia
- Interventions
- Registration Number
- NCT01462578
- Lead Sponsor
- Technische Universität Dresden
- Brief Summary
Assessment of efficacy of azacitidine to prevent a relapse
- Detailed Description
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+ or CD117+ MDS or AML or
* increase in the AML-specific molecular markers in the quantitative PCR for 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 allogeneic 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
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(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,
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Participation of the patient in another clinical trial within the last 4 weeks before the inclusion
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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
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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:
- sexual abstinence
- State post-vasectomy
- Condom
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Evidence that the participating person is not expected to comply with the protocol (such as lack of cooperation)
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Uncontrolled active infection
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Severe hepatic impairment (AST and ALT may not exceed three times the normal) or liver cirrhosis or malignant liver tumor
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Dialysis dependent renal dysfunction
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Azacytidine Azacitidine Azacytidine injection: 75 mg/m²/d, subcutaneous
- Primary Outcome Measures
Name Time Method Number of patients with hematological relapse 6 months after start of treatment with azacitidin 6 months after end of treatment
- Secondary Outcome Measures
Name Time Method Rate of changes of methylation in CD34+ cells 2 years follow-up after treatment Number of occurrence or exacerbation of clinical relevant acute or chronic GvHD 2 years follow-up after treatment Relapse-free survival and overall survival 12, 24 and 30 months after start of treatment Relapse-free survival and overall survival 12, 24 and 30 months after start of treatment
Number of patients with infectious SAEs (rate of SAE) 2 years follow-up after treatment
Trial Locations
- Locations (11)
Klinikum Chemnitz (Küchwald)
🇩🇪Chemnitz, Germany
Universitätsklinikum Bonn
🇩🇪Bonn, Germany
Universitätsklinikum Heidelberg, Medizinische Klinik, Abt. Innere Medizin V
🇩🇪Heidelberg, Germany
Klinikum der J. W. Goethe-Universität, Medizinische Klinik II Hämatologie / Onkologie
🇩🇪Frankfurt am Main, Germany
Klinikum rechts der Isar der TU München, III. Med. Klinik und Poliklinik
🇩🇪München, Germany
Universitätsklinikum Essen, Klinik für Hämatologie (Westdeutsches Tumorzentrum)
🇩🇪Essen, Germany
Charité Campus Benjamin Franklin
🇩🇪Berlin, Germany
Universitätsklinikum Carl Gustav Carus, Medizinische Klinik und Poliklinik I
🇩🇪Dresden, Germany
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
LMU München, Klinikum Großhadern, Med. Klinik III
🇩🇪München, Germany
Universitätsklinikum Münster, Innere Medizin A - KMT-Zentrum
🇩🇪Münster, Germany