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A randomised phase III study to compare arsenic trioxide (ATO) combined to ATRA versus standard ATRA and anthracycline-based chemotherapy (AIDA regimen) for newly diagnosed, non high-risk acute promyelocytic leukemia - AL WP GIMEMA-DSIL APL0406

A randomised phase III study to compare arsenic trioxide (ATO) combined to ATRA versus standard ATRA and anthracycline-based chemotherapy (AIDA regimen) for newly diagnosed, non high-risk acute promyelocytic leukemia - AL WP GIMEMA-DSIL APL0406

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-006188-22-DE
Enrollment
276
Registered
2008-03-25
Start date
2008-08-04
Completion date
Unknown
Last updated
2019-02-28

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

Conditions

Non high-risk acute promyelocytic leukemia MedDRA version: 14.0 Level: PT Classification code 10001019 Term: Acute promyelocytic leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: TRISENOX Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Arsentrioxid Current Sponsor code: ATO

Sponsors

G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Signed written informed consent according to IGH/EU/GCP and national local laws Newly diagnosed APL by cytomorphology, confirmed also by molecular analysis*. Age 18 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Age = 71 WBC at diagnosis > 10 x 109/L Other active malignancy at time of study entry Lack of diagnostic confirmation at genetic level Significant arrhythmias, EKG abnormalities (*see below) or neuropathy Other cardiac contraindications for intensive chemotherapy (L-VEF 450 msec on screening EKG (using the QTcF formula detailed on page 18) Right bundle branch block plus left anterior hemiblock, bifascicular block

Design outcomes

Primary

MeasureTime frame
Main Objective: To compare, in newly diagnosed APL patients treated with arsenic trioxide (ATO) combined to ATRA or receiving ATRA plus chemotherapy (AIDA regimen), the event-free survival (EFS) rate.;Secondary Objective: To compare CR, OS and CIR rates in the two arms To compare the toxicity profile in the two arms To compare the kinetics of MRD in the two arms To compare the duration of patient hospitalisation in the two arms To compare Quality of Life between treatment arms;Primary end point(s): Event-free survival probability at 2 years from diagnosis—

Countries

Austria, Germany, Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026