ClinicalTrials.Veeva

Menu

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

U

University of Ulm

Status and phase

Completed
Phase 3
Phase 2

Conditions

Acute Myeloid Leukemia

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00151242
AMLSG07-04

Details and patient eligibility

About

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).

Full 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

Enrollment

920 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

920 participants in 2 patient groups

1
Active Comparator group
Treatment:
Drug: Cytarabine
Drug: Idarubicin
Drug: Pegfilgrastim
Drug: Etoposide
2
Experimental group
Treatment:
Drug: Cytarabine
Drug: Idarubicin
Drug: Pegfilgrastim
Drug: All-trans retinoic acid
Drug: Etoposide

Trial contacts and locations

34

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems