Clinical Guidelines for APL Treatment

• Sponsor: PETHEMA Foundation (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02020161
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 114
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
APL	Drug: Atra; Drug: Idarubicin; Drug: methotrexate	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Actual Study Start Date: Jun 1, 2012
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ATRA-Idarubicin	Drug: Atra; Drug: Idarubicin; Drug: methotrexate

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Genetic diagnosis of acute promyelocytic leukemia

Exclusion Criteria:

• No exclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital La Fe	Valencia		Spain

Sponsors and Collaborators

• PETHEMA Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: PETHEMA Foundation
• ClinicalTrials.gov Identifier: NCT02020161
• Other Study ID Numbers: PETHEMA LPA2012
• First Posted: Dec 24, 2013
• Last Update Posted: Mar 23, 2021
• Last Verified: Mar 1, 2021

• Additional relevant MeSH terms: Methotrexate; Idarubicin

Study Results

No Results Posted as of Mar 23, 2021