Clinical Guidelines for APL Treatment

Phase 4

• Conditions: APL
• Interventions: Drug: Atra; Drug: Idarubicin; Drug: methotrexate

• Registration Number: NCT02020161
• Lead Sponsor: PETHEMA Foundation

Brief Summary

Therapeutic guidelines for treatment of patients with de novo APL to be used by every institution that wants to follow them. All patients who are reported may be retrospectively analyzed

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-11-26
• Study First Submitted QC: 2013-12-23
• Study First Posted: 2013-12-24
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-22
• Last Update Posted: 2021-03-23
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Genetic diagnosis of acute promyelocytic leukemia

Exclusion Criteria

• No exclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ATRA-Idarubicin	Atra	-
ATRA-Idarubicin	methotrexate	-
ATRA-Idarubicin	Idarubicin	-

Primary Outcome Measures

Name	Time	Method
Recurrence within 1 year of treatment	3 years	Induction therapy with simultaneous ATRA (45 mg/m2 day until CR) and idarubicin (12 mg/m2 day on days 2, 4, 6 and 8 or 12 mg/m2 day on days 2, 4 and 6 in patients older than or equal to 60 years).; Three monthly consolidation courses with ATRA Maintenance therapy with ATRA (45 mg/m2/d, days 1-15 every 3 months), and low dose chemotherapy with methotrexate (15 mg/m2/d, weekly) and 6-mercaptopurine (50 mg/m2/d) for two years.

Trial Locations

Locations (1)

Hospital La Fe; 🇪🇸 Valencia, Spain