Trial document





This trial has been registered retrospectively.
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  DRKS00003225

Trial Description

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Title

Randomized phase III study comparing the OSHO arm to the standard therapy arm of Geman AML Intergroup.

Randomized comparison of Cytarabine and Mitoxantrone versus Fludarabine, Cytarabine, Mitoxantron and G-CSF treatment in patients not in remission after the first induction chemotherapy.

Randomized comparison between one or two chemotherapy consolidation courses before autologous or allogeneic human stem cell transplantation in adult patients with AML under the age of 60 years.

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Trial Acronym

AML 2002 #061

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URL of the Trial

http://www.kompetenznetz-leukaemie.de/trial/detail.html?id=22

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Brief Summary in Lay Language

The clinical study is part of a cooperation of five German study groups (German AML Intergroup). In addition to the comparison of the efficiency of the therapy strategies among the single study groups, separate questions from each study group were retained and supported. By changing to a second different induction chemotherapy instead of the repetition of the first cycle, they hope for a higher response rate (number of complete remissions) in patients not in remission after the first induction chemotherapy.

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Brief Summary in Scientific Language

Randomized phase 3 study comparison of Mito/FLAG versus Mitoxantron/AraC treatment in patients not in remission after the first induction chemotherapy Randomized comparison between one or two chemotherapy consolidation courses before autologous or allogeneic human stem cell transplantation in adult patients with newly diagnosed AML under the age of 60 years

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00003225
  •   2011/08/16
  •   2006/06/29
  •   yes
  •   Approved
  •   027/2002, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

  •   4022966 
  •   LN_AMLOSH_2002_22  (Kompetenznetz Leukämie)
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Health Condition or Problem studied

  •   acute myeloid leukaemia
  •   C92.0 -  Acute myeloid leukaemia
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Interventions/Observational Groups

  •   Cytarabine: 2 x 1 g/m²; 3-h-iv infusion a 12 h; day 1+3+5+7.
    Mitoxantrone: 10 mg/m²; 30-min-iv infusion; day 1 - 3.

  •   Fludarabine: 2 x 15 mg/m²; 30-min-iv infusion; day 1-5 ( 8:00 and 20:00).
    Cytarabine: 2 x 1 g/m²; 1-h-iv infusion; day 1-5 (12:00 and 24: 00).
    Mitoxantrone: 7 mg/m²; 30-min-iv infusion; day 1+3+5 (19:30).
    G-CSF (Neupogen): 5 µg/kg; sc or 24-h-iv infusion; day 0 up to ANC > 0,5 x 10e9/l (12:00).
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

Rate of complete remission after treatment with Cytarabine/Mitoxantrone versus Fludarabine/Cytarabine/Mitoxantrone/G-CSF given as second induction chemotherapy in patients not in remission after the first induction chemotherapy. Response assessment using bone marrow cytology is scheduled after hematological reconstitution after second induction therapy. The induction chemotherapy is finished with the second treatment course.

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Secondary Outcome

5-year survival and leukemia-free survival

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Countries of Recruitment

  •   Germany
  •   Austria
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2002/04/04
  •   730
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   60   Years
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Additional Inclusion Criteria

--> age >=18 years and <=60 years

--> newly diagnosed acute myeloid leukemia as defined by new WHO classification

--> Myelodysplastic Syndrome RAEB-T according to FAB-classification (blasts in bone-marrow 20-30%)

--> de novo AML, secondary AML (patients with a history of myelodysplasia or other antecedent hematologic disorder for at least 6 months or therapy-related AML after previous exposure to cytotoxic drugs or radiotherapy)

-->patients written informed consent

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Exclusion Criteria

--> AML FAB M3 - acute promyelocyte leukemia

--> involvement in other clinical trials

--> contraindication to intensive chemotherapy:

--> Renal failure not AML-related

--> Hepatic insufficiency not AML-related

--> Cardiac insufficiency NYHA III + IV

--> Uncontrolled infection

--> Pregnancy

--> Karnofsky-performance-score 10

--> Secondary malignancies

--> Severe, decompensated metabolic disorders

--> HIV

--> mental impairment with inability to give consent

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Addresses

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    • Universitätsklinikum Leipzig Hämatologie/Onkologie
    • Mr.  Prof. Dr. med. Dr. h. c.  Dietger  Niederwieser 
    • Johnnisallee 32A
    • 04103  Leipzig
    • Germany
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    • Universitätsklinikum Leipzig Hämatologie/Onkologie
    • Mr.  Prof. Dr. med. Dr. h. c.   Dietger  Niederwieser 
    • Johannisallee 32A
    • 04103  Leipzig
    • Germany
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    • Universität Leipzig Hämatologie/Onkologie
    • Mr.  Prof. Dr. med. Dr. h. c.   Dietger  Niederwieser 
    • Johannisallee 32A
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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* This entry means the parameter is not applicable or has not been set.