Clinical Guidelines for APL Treatment

APL Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02020161
• Other study ID #: PETHEMA LPA2012
• Status: Recruiting
• Phase: Phase 4
• Start date: June 2012
• Est. completion date: December 2021

Study information

• Verified date: March 2021
• Source: PETHEMA Foundation
• Contact: Pau Montesinos, Dr
• Phone: +34 96 1244000
• Email: montesinos_pau[@]gva.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Genetic diagnosis of acute promyelocytic leukemia

Exclusion Criteria:

• No exclusion criteria

Related Conditions & MeSH terms

• APL

Intervention

Drug:
• Atra

• Idarubicin

• methotrexate

Locations

Country	Name	City	State
Spain	Hospital La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
PETHEMA Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence within 1 year of treatment	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.	3 years