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

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)

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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