Clinical Trials /

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

NCT01462578

Description:

Assessment of efficacy of azacitidine to prevent a relapse

Related Conditions:
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndromes
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Treatment of Patients With Myelodysplastic Syndrome or Acute Myelocytic Leukemia With an Impending Hematological Relapse With Azacitidine (Vidaza)
  • Official Title: Treatment of Patients With MDS or AML With an Impending Hematological Relapse With Azacitidine (Vidaza)

Clinical Trial IDs

  • ORG STUDY ID: TUD-RELA02-048
  • SECONDARY ID: 2010-022388-37
  • SECONDARY ID: VZ-MDS-PI-0245
  • NCT ID: NCT01462578

Conditions

  • Acute Myelocytic Leukemia
  • Myelodysplastic Syndrome

Interventions

DrugSynonymsArms
AzacitidineVidaza®Azacytidine

Purpose

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
    

Trial Arms

NameTypeDescriptionInterventions
AzacytidineExperimentalAzacytidine injection: 75 mg/m²/d, subcutaneous
  • Azacitidine

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of patients with hematological relapse 6 months after start of treatment with azacitidin
Time Frame:6 months after end of treatment
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Number of occurrence or exacerbation of clinical relevant acute or chronic GvHD
Time Frame:2 years follow-up after treatment
Safety Issue:
Description:
Measure:Number of patients with infectious SAEs (rate of SAE)
Time Frame:2 years follow-up after treatment
Safety Issue:
Description:
Measure:Rate of changes of methylation in CD34+ cells
Time Frame:2 years follow-up after treatment
Safety Issue:
Description:
Measure:Relapse-free survival and overall survival
Time Frame:12, 24 and 30 months after start of treatment
Safety Issue:
Description:Relapse-free survival and overall survival 12, 24 and 30 months after start of treatment

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Technische Universität Dresden

Trial Keywords

  • Neoplasms benign, malignant and unspecified
  • Acute myeloid leukemia
  • AML
  • Myelodysplastic syndrome
  • MDS

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