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

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ClinicalTrials.gov Identifier: NCT00151242
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Richard Schlenk, University of Ulm

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Cytarabine Drug: Idarubicin Drug: Etoposide Drug: All-trans retinoic acid Drug: Pegfilgrastim Phase 2 Phase 3

Detailed Description:

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 920 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : July 2004
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1 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: Pegfilgrastim
6mg s.c day 10 (cohort 1), 6mg s.c. day 8 (cohort 2)
Other Name: Neulasta
Experimental: 2 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


Outcome Measures
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Primary Outcome Measures :
  1. Complete remission (CR)-rate after induction therapy [ Time Frame: after the second induction cycle ]
  2. 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 ]
  3. Event-free survival [ Time Frame: two years ]

Secondary Outcome Measures :
  1. Kind, incidence, severity, temporal sequence and correlation of side effects of the study-drugs [ Time Frame: during therapy ]
  2. Cumulative incidence of relapse [ Time Frame: two years ]
  3. Cumulative incidence of death [ Time Frame: two years ]
  4. Overall survival [ Time Frame: two years ]
  5. Hematological recovery as well as incidence and duration of infections during neutropenia after each consolidation cycle [ Time Frame: during consolidation therapy ]
  6. Timely sequence of the pegfilgrastim-concentration in correlation to the absolute neutrophil counts after each consolidation cycle [ Time Frame: during consolidation therapy ]
  7. 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 ]
  8. Days in hospital after each consolidation cycle [ Time Frame: after consolidation therapy ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00151242


Locations
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Sponsors and Collaborators
University of Ulm
Investigators
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Principal Investigator: Richard F Schlenk, Dr. University of Ulm
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prof. Dr. Richard Schlenk, PD Dr., University of Ulm
ClinicalTrials.gov Identifier: NCT00151242    
Other Study ID Numbers: AMLSG07-04
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Etoposide
Idarubicin
Tretinoin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Keratolytic Agents
Dermatologic Agents