Treatment of Patients With Myelodysplastic Syndrome or Acute Myelocytic Leukemia With an Impending Hematological Relapse With Azacitidine (Vidaza) (RELAZA2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Technische Universität Dresden
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT01462578
First received: June 22, 2011
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

Assessment of efficacy of azacitidine to prevent a relapse


Condition Intervention Phase
Acute Myelocytic Leukemia
Myelodysplastic Syndrome
Drug: Azacitidine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Patients With MDS or AML With an Impending Hematological Relapse With Azacitidine (Vidaza)

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • Number of patients with hematological relapse 6 months after start of treatment with azacitidin [ Time Frame: 6 months after end of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of occurrence or exacerbation of clinical relevant acute or chronic GvHD [ Time Frame: 2 years follow-up after treatment ] [ Designated as safety issue: No ]
  • Number of patients with infectious SAEs (rate of SAE) [ Time Frame: 2 years follow-up after treatment ] [ Designated as safety issue: Yes ]
  • Rate of changes of methylation in CD34+ cells [ Time Frame: 2 years follow-up after treatment ] [ Designated as safety issue: No ]
  • Relapse-free survival and overall survival [ Time Frame: 12, 24 and 30 months after start of treatment ] [ Designated as safety issue: Yes ]
    Relapse-free survival and overall survival 12, 24 and 30 months after start of treatment


Estimated Enrollment: 53
Study Start Date: September 2011
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azacytidine
injection: 75 mg/m²/d, subcutaneous
Drug: Azacitidine
injection: 75 mg/m²/d, subcutaneous; initial minimum 6 cycles; another 6 or 12 cycles according to MRD niveau; maximum 24 cycles
Other Name: Vidaza®

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(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 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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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+ 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(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)

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01462578

Contacts
Contact: Uwe Platzbecker, Prof. Dr. med. Uwe.Platzbecker@uniklinikum-dresden.de
Contact: Jana Hase Jana.Hase@uniklinikum-dresden.de

Locations
Germany
Charité Campus Benjamin Franklin Recruiting
Berlin, Germany
Contact: Claudia Baldus, Prof. Dr. med.       claudia.baldus@charite.de   
Principal Investigator: Claudia Baldus, Prof.         
Universitätsklinikum Bonn Not yet recruiting
Bonn, Germany
Contact: Dominik Wolf, Prof. Dr. med.         
Principal Investigator: Dominik Wolf, Prof. Dr. med.         
Klinikum Chemnitz (Küchwald) Recruiting
Chemnitz, Germany
Contact: Regina Herbst, Dr. med.       r.herbst@skc.de   
Principal Investigator: Mathias Hänel, PD Dr.         
Universitätsklinikum Carl Gustav Carus, Medizinische Klinik und Poliklinik I Recruiting
Dresden, Germany
Contact: Uwe Platzbecker, Prof. Dr. med.       uwe.platzbecker@uniklinikum-dresden.de   
Contact: Martin Wermke, Dr. med.       martin.wermke@uniklinikum-dresden.de   
Principal Investigator: Uwe Platzbecker, Prof. Dr. med.         
Universitätsklinikum Essen, Klinik für Hämatologie (Westdeutsches Tumorzentrum) Recruiting
Essen, Germany
Contact: Richard Noppeney, Dr. med.       richard.noppeney@uk-essen.de   
Principal Investigator: Richard Noppeney, Dr. med.         
Klinikum der J. W. Goethe-Universität, Medizinische Klinik II Hämatologie / Onkologie Not yet recruiting
Frankfurt am Main, Germany
Contact: Gesine Bug, PD Dr. med.       g.bug@em.uni-frankfurt.de   
Principal Investigator: Gesine Bug, PD Dr. med.         
Universitätsklinikum Heidelberg, Medizinische Klinik, Abt. Innere Medizin V Recruiting
Heidelberg, Germany
Contact: Alwin Krämer, Prof. Dr. med.       Alwin.Kraemer@med.uni-heidelberg.de   
Contact: Tilmann Bochtler, Dr. med.       tilmann.bochtler@med.uni-heidelberg.de   
Principal Investigator: Alwin Krämer, Prof.         
LMU München, Klinikum Großhadern, Med. Klinik III Recruiting
München, Germany
Contact: Friederike Pastore, Dr. med.         
Contact: Stefani Lippl, Dr. med.         
Principal Investigator: Karsten Spiekermann, Prof.         
Klinikum rechts der Isar der TU München, III. Med. Klinik und Poliklinik Recruiting
München, Germany
Contact: Katharina Götze, PD Dr. med.       K.Goetze@lrz.tu-muenchen.de   
Principal Investigator: Katharina Götze, PD Dr. med.         
Universitätsklinikum Münster, Innere Medizin A - KMT-Zentrum Recruiting
Münster, Germany
Contact: Matthias Stelljes, Prof. Dr. med.       stelljes@uni-muenster.de   
Principal Investigator: Matthias Stelljes, Prof. Dr. med.         
Sponsors and Collaborators
Technische Universität Dresden
Investigators
Principal Investigator: Uwe Platzbecker, Prof. Dr. med. Universitätsklinikum Carl Gustav Carus, Medizinische Klinik und Poliklinik I, 01307 Dresden
  More Information

Additional Information:
No publications provided

Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT01462578     History of Changes
Other Study ID Numbers: TUD-RELA02-048, 2010-022388-37, VZ-MDS-PI-0245
Study First Received: June 22, 2011
Last Updated: April 3, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität Dresden:
Neoplasms benign, malignant and unspecified
Acute myeloid leukemia
AML
Myelodysplastic syndrome
MDS

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 28, 2014