All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia

U

University of Ulm

Status and phase

Completed
Phase 3

Conditions

Acute Myeloid Leukemia

Treatments

Drug: Cytarabine
Drug: Etoposid
Drug: Idarubicin
Drug: Mitoxantrone
Drug: All-trans retinoic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT00151255
AMLSG06-04

Details and patient eligibility

About

This is a study looking at all-trans retinoic acid in combination with standard induction and consolidation therapy in older patients with newly diagnosed acute myeloid leukemia (AML).

Full description

First Induction Therapy: Cytarabine 100 mg/m² cont. i.v. days 1-5 Idarubicin 12 mg/m² i.v. days 1, 3 ATRA 45 mg/m² p.o. days 4-6, ATRA 15 mg/m² p.o. days 7-28 Second Induction Therapy: Cytarabine 100 mg/m² cont. i.v. days 1-5 Idarubicin 12 mg/m² i.v. days 1, 3 ATRA 45 mg/m² p.o. days 4-6, ATRA 15 mg/m² p.o. days 7-28 First Consolidation Therapy: Cytarabine 1000 mg/m² bid i.v. days 1-3 Mitoxantrone 10 mg/m² i.v. days 2, 3 ATRA 15 mg/m² p.o. days 4-28 Second Consolidation Therapy Etoposide 100 mg/m² i.v. days 1-5 Idarubicin 12 mg/m² i.v. days 1,3 ATRA 15 mg/m² p.o. days 4-28

Enrollment

500 estimated patients

Sex

All

Ages

61+ 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])
  • Aged > 60 years
  • All patients have to be informed about the character of the study. Written informed consent of each patient at study entry.
  • Molecular and cytogenetical analyses on initial bone marrow and peripheral blood specimen have to be performed at the central reference laboratories.

Exclusion criteria

  • Bleeding independent of the AML
  • Acute promyelocytic leukemia
  • Uncontrolled infection
  • Participation in a concurrent clinical study
  • Insufficiency of the kidneys (creatinine > 1.5 x upper normal serum level), of the liver (bilirubin, AST or AP > 2 x upper normal serum level), severe obstruction or restrictive ventilation disorder, heart failure New York Heart Association [NYHA] III/IV
  • Severe neurological or psychiatric disorder interfering with ability of giving informed consent
  • No consent for the registration, storage and processing of data concerning the characteristics of the AML and the individual course
  • Performance status WHO > 2

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

29

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Data sourced from clinicaltrials.gov

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