Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007134

Trial Description

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Title

Treatment of Patients With MDS or AML With an Impending Hematological Relapse With Azacitidine (Vidaza)

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Trial Acronym

RELAZA2

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Assessment of efficacy of azacitidine to prevent a relapse

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Brief Summary in Scientific Language

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

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Organizational Data

  •   DRKS00007134
  •   2014/11/17
  •   2011/06/22
  •   yes
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Secondary IDs

  •   2010-022388-37 
  •   NCT01462578  (ClinicalTrials.gov)
  •   TUD-RELA02-048  (Technische Universität Dresden)
  •   2010-022388-37 
  •   VZ-MDS-PI-0245 
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Health Condition or Problem studied

  •   Acute Myelocytic Leukemia
  •   Myelodysplastic Syndrome
  •   C92.0 -  Acute myeloblastic leukaemia [AML]
  •   D46 -  Myelodysplastic syndromes
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Interventions/Observational Groups

  •   Drug: Azacitidine
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
  •   [---]*
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Primary Outcome

- Number of patients with hematological relapse 6 months after start of treatment with azacitidin; time frame: 6 months after end of treatment

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Secondary Outcome

- 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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2011/09/30
  •   53
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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)

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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.

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Addresses

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    • Technische Universität Dresden
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    • Universitätsklinikum Carl Gustav Carus, Medizinische Klinik und Poliklinik I, 01307 Dresden
    • Uwe Platzbecker, Prof. Dr. med. 
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    • Uwe Platzbecker, Prof. Dr. med. 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   13
  •   2014/10/27
* This entry means the parameter is not applicable or has not been set.