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

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ClinicalTrials.gov Identifier: NCT01462578
Recruitment Status : Active, not recruiting
First Posted : October 31, 2011
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden

Tracking Information
First Submitted Date  ICMJE June 22, 2011
First Posted Date  ICMJE October 31, 2011
Last Update Posted Date December 10, 2018
Study Start Date  ICMJE September 2011
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2011)
Number of patients with hematological relapse 6 months after start of treatment with azacitidin [ Time Frame: 6 months after end of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01462578 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2011)
  • Number of occurrence or exacerbation of clinical relevant acute or chronic GvHD [ Time Frame: 2 years follow-up after treatment ]
  • Number of patients with infectious SAEs (rate of SAE) [ Time Frame: 2 years follow-up after treatment ]
  • Rate of changes of methylation in CD34+ cells [ Time Frame: 2 years follow-up after treatment ]
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Patients With Myelodysplastic Syndrome or Acute Myelocytic Leukemia With an Impending Hematological Relapse With Azacitidine (Vidaza)
Official Title  ICMJE Treatment of Patients With MDS or AML With an Impending Hematological Relapse With Azacitidine (Vidaza)
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Myelocytic Leukemia
  • Myelodysplastic Syndrome
Intervention  ICMJE 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®
Study Arms  ICMJE Experimental: Azacytidine
Azacytidine injection: 75 mg/m²/d, subcutaneous
Intervention: Drug: Azacitidine
Publications * Platzbecker U, Middeke JM, Sockel K, Herbst R, Wolf D, Baldus CD, Oelschlägel U, Mütherig A, Fransecky L, Noppeney R, Bug G, Götze KS, Krämer A, Bochtler T, Stelljes M, Groth C, Schubert A, Mende M, Stölzel F, Borkmann C, Kubasch AS, von Bonin M, Serve H, Hänel M, Dührsen U, Schetelig J, Röllig C, Kramer M, Ehninger G, Bornhäuser M, Thiede C. Measurable residual disease-guided treatment with azacitidine to prevent haematological relapse in patients with myelodysplastic syndrome and acute myeloid leukaemia (RELAZA2): an open-label, multicentre, phase 2 trial. Lancet Oncol. 2018 Dec;19(12):1668-1679. doi: 10.1016/S1470-2045(18)30580-1. Epub 2018 Nov 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 13, 2017)
93
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2011)
53
Estimated Study Completion Date  ICMJE August 2020
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01462578
Other Study ID Numbers  ICMJE TUD-RELA02-048
2010-022388-37 ( EudraCT Number )
VZ-MDS-PI-0245 ( Other Identifier: Celgene )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Technische Universität Dresden
Study Sponsor  ICMJE Technische Universität Dresden
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Uwe Platzbecker, Prof. Dr. Universitätsklinikum Carl Gustav Carus, Medizinische Klinik und Poliklinik I, 01307 Dresden
PRS Account Technische Universität Dresden
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP