Study on All-Trans Retinoic Acid, Induction and Consolidation Therapy, and Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Richard Schlenk, University of Ulm
ClinicalTrials.gov Identifier:
NCT00151242
First received: September 6, 2005
Last updated: July 22, 2014
Last verified: July 2014

September 6, 2005
July 22, 2014
July 2004
August 2011   (final data collection date for primary outcome measure)
  • Complete remission (CR)-rate after induction therapy [ Time Frame: after the second induction cycle ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Event-free survival [ Time Frame: two years ] [ Designated as safety issue: No ]
CR-rate after induction therapy
Complete list of historical versions of study NCT00151242 on ClinicalTrials.gov Archive Site
  • Kind, incidence, severity, temporal sequence and correlation of side effects of the study-drugs [ Time Frame: during therapy ] [ Designated as safety issue: No ]
  • Cumulative incidence of relapse [ Time Frame: two years ] [ Designated as safety issue: No ]
  • Cumulative incidence of death [ Time Frame: two years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: two years ] [ Designated as safety issue: No ]
  • Hematological recovery as well as incidence and duration of infections during neutropenia after each consolidation cycle [ Time Frame: during consolidation therapy ] [ Designated as safety issue: Yes ]
  • Timely sequence of the pegfilgrastim-concentration in correlation to the absolute neutrophil counts after each consolidation cycle [ Time Frame: during consolidation therapy ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Days in hospital after each consolidation cycle [ Time Frame: after consolidation therapy ] [ Designated as safety issue: Yes ]
  • Kind, incidence, severity, temporal sequence and correlation of side effects of the study-drugs
  • cumulative incidence of relapse
  • cumulative incidence of death
  • Overall survival
  • Event-free survival
  • Hematological recovery as well as incidence and duration of infections during neutropenia after each consolidation cycle Days in hospital after each consolidation cycle
  • Timely sequence of the Pegfilgrastim-concentration in correlation to the absolute neutrophile counts after each consolidation cycle
Not Provided
Not Provided
 
Study on All-Trans Retinoic Acid, Induction and Consolidation Therapy, and Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia
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

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).

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
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myeloid Leukemia
  • Drug: Cytarabine
    100mg/m² kont. i.v. day 1-7 (induction therapy) 3g/m² 2x/die i.v. day 1,3,5 or day 1,2,3
  • Drug: Idarubicin
    12mg/m² i.v. day 1,3,5 (first induction cycle) 12mg/m² i.v. Tag 1,3 (second induction cycle)
  • Drug: Etoposide
    100mg/m² i.v. day 1-3 (induction therapy)
  • Drug: All-trans retinoic acid
    45mg/m² p.o. day 6-8 (induction therapy) 15mg/m² p.o. day 9-21 (induction therapy) 15mg/m² p.o. day 6-21 (consolidation therapy)
  • Drug: Pegfilgrastim
    6mg s.c day 10 (cohort 1), 6mg s.c. day 8 (cohort 2)
    Other Name: Neulasta
  • Active Comparator: 1
    Interventions:
    • Drug: Cytarabine
    • Drug: Idarubicin
    • Drug: Etoposide
    • Drug: Pegfilgrastim
  • Experimental: 2
    Interventions:
    • Drug: Cytarabine
    • Drug: Idarubicin
    • Drug: Etoposide
    • Drug: All-trans retinoic acid
    • Drug: Pegfilgrastim

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
920
August 2013
August 2011   (final data collection date for primary outcome measure)

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

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
 
NCT00151242
AMLSG07-04
Not Provided
Dr. Richard Schlenk, University of Ulm
University of Ulm
Not Provided
Principal Investigator: Richard F Schlenk, Dr. Department of Internal Medicine III, University of Ulm
University of Ulm
July 2014

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