NCT02020161

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 24, 2013

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

9.5 years

First QC Date

November 26, 2013

Last Update Submit

March 22, 2021

Conditions

APL

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

ATRA-Idarubicin

EXPERIMENTAL
Drug: AtraDrug: IdarubicinDrug: methotrexate

Interventions

AtraDRUG
ATRA-Idarubicin
IdarubicinDRUG
ATRA-Idarubicin
methotrexateDRUG
ATRA-Idarubicin

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Genetic diagnosis of acute promyelocytic leukemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital La Fe

Valencia, Spain

RECRUITING

MeSH Terms

Interventions

TretinoinIdarubicinMethotrexate

Intervention Hierarchy (Ancestors)

Vitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological FactorsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Pau Montesinos, Dr

CONTACT

+34 96 1244000montesinos_pau@gva.es

David Martinez, Dr

CONTACT

+34 96 1244000.martinez_davcua@gva.es

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2013

First Posted

December 24, 2013

Study Start

June 1, 2012

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

March 23, 2021

Record last verified: 2021-03

Locations

ES(1)