NCT00151242

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 920 (actual)
• Sponsor: University of Ulm · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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).

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

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2004-07-01
• Primary completion: 2011-08-01
• Completion: 2013-08-01
• First posted: 2005-09-08
• Last updated: 2017-09-20

Locations

34 sites across 2 countries: Austria, Germany