We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01462578
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01462578
Recruitment Status : Completed
First Posted : October 31, 2011
Last Update Posted : November 15, 2021
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Assessment of efficacy of azacitidine to prevent a relapse

Condition or disease Intervention/treatment Phase
Acute Myelocytic Leukemia Myelodysplastic Syndrome Drug: Azacitidine Phase 2

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
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Patients With MDS or AML With an Impending Hematological Relapse With Azacitidine (Vidaza)
Study Start Date : September 2011
Actual Primary Completion Date : August 2018
Actual Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Azacitidine

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Azacytidine
Azacytidine injection: 75 mg/m²/d, subcutaneous
 Drug: Azacitidine
Azacytidine 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®


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of patients with hematological relapse 6 months after start of treatment with azacitidin [ Time Frame: 6 months after end of treatment ]

Secondary Outcome Measures :
  1. Number of occurrence or exacerbation of clinical relevant acute or chronic GvHD [ Time Frame: 2 years follow-up after treatment ]
  2. Number of patients with infectious SAEs (rate of SAE) [ Time Frame: 2 years follow-up after treatment ]
  3. Rate of changes of methylation in CD34+ cells [ Time Frame: 2 years follow-up after treatment ]
  4. Relapse-free survival and overall survival [ Time Frame: 12, 24 and 30 months after start of treatment ]
    Relapse-free survival and overall survival 12, 24 and 30 months after start of treatment


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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(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)

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 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:

    • 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01462578


Locations
Layout table for location information
Germany
Charité Campus Benjamin Franklin
Berlin, Germany
Universitätsklinikum Bonn
Bonn, Germany
Klinikum Chemnitz (Küchwald)
Chemnitz, Germany
Universitätsklinikum Carl Gustav Carus, Medizinische Klinik und Poliklinik I
Dresden, Germany
Universitätsklinikum Essen, Klinik für Hämatologie (Westdeutsches Tumorzentrum)
Essen, Germany
Klinikum der J. W. Goethe-Universität, Medizinische Klinik II Hämatologie / Onkologie
Frankfurt am Main, Germany
Universitätsklinikum Freiburg
Freiburg, Germany
Universitätsklinikum Heidelberg, Medizinische Klinik, Abt. Innere Medizin V
Heidelberg, Germany
Klinikum rechts der Isar der TU München, III. Med. Klinik und Poliklinik
München, Germany
LMU München, Klinikum Großhadern, Med. Klinik III
München, Germany
Universitätsklinikum Münster, Innere Medizin A - KMT-Zentrum
Münster, Germany
Sponsors and Collaborators
Technische Universität Dresden
Investigators
Layout table for investigator information
Principal Investigator: Uwe Platzbecker, Prof. Dr. Universitätsklinikum Carl Gustav Carus, Medizinische Klinik und Poliklinik I, 01307 Dresden
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications of Results:

Layout table for additonal information
Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT01462578    
Other Study ID Numbers: TUD-RELA02-048
2010-022388-37 ( EudraCT Number )
VZ-MDS-PI-0245 ( Other Identifier: Celgene )
First Posted: October 31, 2011    Key Record Dates
Last Update Posted: November 15, 2021
Last Verified: November 2021
Keywords provided by Technische Universität Dresden:
Neoplasms benign, malignant and unspecified
Acute myeloid leukemia
AML
Myelodysplastic syndrome
MDS
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Preleukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
 Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors