Clinical Guidelines for APL Treatment

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02020161

Enrollment

200

Registered

2013-12-24

Start date

2012-06-30

Completion date

2021-12-31

Last updated

2021-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

APL

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

Interventions

DRUGAtra

DRUGIdarubicin

DRUGmethotrexate

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Genetic diagnosis of acute promyelocytic leukemia

Exclusion criteria

* No

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Spain

Contacts

Primary ContactPau Montesinos, Dr

montesinos_pau@gva.es+34 96 1244000

Backup ContactDavid Martinez, Dr

martinez_davcua@gva.es+34 96 1244000.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026