NCT00151255

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: University of Ulm · Academic / Other
• Sex: All
• Age: 61 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Cytarabine	100mg/m² kont. i.v. day 1-5 (induction therapy); 1000 mg/m² 2x/die i.v. day 1-3 (first consolidation cycle)
DRUG	Idarubicin	12mg/m² i.v. day 1+3 (induction therapy); 12mg/m² i.v. Tag 1+3 (second consolidation cycle)
DRUG	All-trans retinoic acid	45mg/m² p.o. day 4-6, 15mg/m² p.o. day 7-28 (induction therapy); 15mg/m² p.o. day 4-28 (consolidation therapy)
DRUG	Mitoxantrone	10mg/m² i.v. day 2-3 (first consolidation cycle)
DRUG	Etoposid	100mg/m² i.v. Tag 1-5 (second consolidation cycle)

Timeline

• Start date: 2004-06-01
• Primary completion: 2009-06-01
• Completion: 2011-01-01
• First posted: 2005-09-08
• Last updated: 2017-04-19

Locations

29 sites across 2 countries: Austria, Germany