Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003818

Trial Description

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Title

Randomized Phase II/III-Study on All-Trans Retinoic Acid in Combination With Induction and Consolidation Therapy as Well as Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This trial is a study on all-trans retinoic acid in combination with induction and
consolidation therapy as well as pegfilgrastim after consolidation therapy in younger
patients with newly diagnosed acute myeloid leukemia (AML).

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Brief Summary in Scientific Language

First Induction Therapy:

- Cytarabine 100 mg/m² cont. i.v. days 1-7

- Idarubicin 12 mg/m² i.v. days 1,3,5

- Etoposide 100 mg/m² i.v. days 1-3

- ± ATRA 45 mg/m² p.o. days 6-8

- ATRA 15 mg/m² p.o. days 9-21

Second Induction Therapy:

- Cytarabine 100 mg/m² cont. i.v. days 1-7

- Idarubicin 12 mg/m² i.v. days 1 and 3

- Etoposide 100 mg/m² i.v. days 1-3

- ± ATRA 45 mg/m² p.o. days 6-8

- ATRA 15 mg/m² p.o. days 9-21

Consolidation Therapy:

cohort 1 (<= ID 336)

- Cytarabine 3 g/m² 2x/die i.v. Tag 1,3,5

- ± ATRA 15 mg/m² p.o. Tag 6-21

- Pegfilgrastim 6 mg s.c day 10

cohort 2 (> ID 336)

- Cytarabine 3 g/m² 2x/die i.v. Tag 1,2,3

- ± ATRA 15 mg/m² p.o. Tag 4-21

- Pegfilgrastim 6 mg s.c day 8

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Organizational Data

  •   DRKS00003818
  •   2012/05/07
  •   2005/09/06
  •   yes
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Secondary IDs

  •   NCT00151242  (ClinicalTrials.gov)
  •   AMLSG07-04  (University of Ulm)
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Health Condition or Problem studied

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

  •   Drug: Cytarabine
  •   Drug: Idarubicin
  •   Drug: Etoposide
  •   Drug: All-trans retinoic acid
  •   Drug: Pegfilgrastim
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II-III
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Primary Outcome

- Complete remission (CR)-rate after induction therapy; time frame: after the second induction cycle
- Relapse-free survival, one year after consolidation therapy with high-dose cytarabine considering different temporal sequences (1-3-5 versus 1-2-3) of the consolidation therapy; time frame: One year after consolidation therapy
- Event-free survival; time frame: two years

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Secondary Outcome

- Kind, incidence, severity, temporal sequence and correlation of side effects of the study-drugs; time frame: during therapy
- Cumulative incidence of relapse; time frame: two years
- Cumulative incidence of death; time frame: two years
- Overall survival; time frame: two years
- Hematological recovery as well as incidence and duration of infections during neutropenia after each consolidation cycle; time frame: during consolidation therapy
- Timely sequence of the pegfilgrastim-concentration in correlation to the absolute neutrophil counts after each consolidation cycle; time frame: during consolidation therapy
- Hematologic and non-hematologic toxicity after consolidation therapy with high-dose cytarabine considering the different consolidation schemes (day 1-3-5 versus day 1-2-3); time frame: during consolidation therapy
- Days in hospital after each consolidation cycle; time frame: after consolidation therapy

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Countries of Recruitment

  •   Austria
  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2004/07/31
  •   920
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

- Newly diagnosed AML defined according to the World Health Organization
(WHO)-classification (excluding acute promyelocytic leukemia [APL])

- Ages 18-60 years

- Written informed consent of each patient at study entry.

- Molecular and cytogenetical diagnostics on initial bone marrow and peripheral blood
specimen at the central reference laboratories

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Exclusion Criteria

- Bleeding independent of the AML

- Acute promyelocytic leukemia

- Uncontrollable infection

- Participation in a concurrent clinical study

- Insufficiency of the kidneys (creatinine > 1.5x upper normal serum level), of the
liver (bilirubin, AST or AP > 2x upper normal serum level), severe obstructive or
restrictive ventilation disorder, heart failure New York Heart Association (NYHA)
III/IV

- Severe neurological or psychiatric disorder interfering with ability to give an
informed consent.

- No consent for registration, storage and processing of the individual
disease-characteristics and course.

- Performance status WHO > 2

- Pregnancy

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Addresses

  • start of 1:1-Block address primary-sponsor
    • University of Ulm
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    • Department of Internal Medicine III, University of Ulm
    • Richard F Schlenk, Dr. 
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    • Department of Internal Medicine III, University of Ulm
    • Richard F Schlenk, Dr. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up continuing
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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 .
  •   11
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.