Therapy of the Young Adult Acute Lymphoblastic Leukemia (ALL): treatment intensification of the pediatric protocol AIEOP LLA-2000 - GIMEMA LAL 1308

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-016075-30-IT

Enrollment

Registered

2010-07-20

Start date

2010-07-09

Completion date

Unknown

Last updated

2018-02-19

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

Conditions

Acute Lymphoblastic Leukemia (ALL) MedDRA version: 9.1 Level: LLT Classification code 10000844

Interventions

Pharmaceutical Form: Solution for injection INN or Proposed INN: Doxorubicin Concentration type: equal Pharmaceutical Form: Solution for injection INN or Proposed INN: Calcium levofolinate Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ALL not-B mature, not Ph+ patients, phenotype line T (LLA-T) or B (LLA-B), aged =18 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Age 2.5 mg / dl after adequate hydration - Patients with transaminases > 3 times the maximum normal value - Patients with left ventricular ejection fraction (FEV) <50% - Patients with a severe mental illness - Presence of concomitant malignant diseases - Presence of documented infections not responding to antibiotic and / or antifungal therapy - Pregnant women or lactating - Down Syndrome.

Design outcomes

Primary

Measure	Time frame
Main Objective: Protocol feasibility - according to the Pediatric Protocol AIEOP LLA-2000, in young adults (age =18 and <35 years) with ALL, not B-mature, not Ph+ - in terms of proportion of patients in-study, alive and in complete remission, and eligible to continue protocol therapy at 8 months after diagnosis.;Secondary Objective: - CR rate after induction therapy - Overall survival (OS), Disease Free Survival (DFS) and the event-free survival (EFS) - Retrospective comparison of results versus patients with the same clinical characteristics registered in previous GIMEMA studies - Toxicity evaluation (grade III-IV events) of the Adriblastina and Dexamethasone re-induction phase - Treatment compliance in terms of dose intensity (drugs cumulative doses; interval therapy).;Primary end point(s): Feasibility evaluation - proportion of patients alive and in complete remission, still in study and eligible to continue it, 8 months after diagnosis - the following events will be considered: - grade III-IV toxicities implying an off-study event (both during induction phase Ia and Ib) and in the consolidation, including the high dose MTX - deaths - no-response after the induction phase - relapses	—

Measure

Time frame

Main Objective: Protocol feasibility - according to the Pediatric Protocol AIEOP LLA-2000, in young adults (age =18 and <35 years) with ALL, not B-mature, not Ph+ - in terms of proportion of patients in-study, alive and in complete remission, and eligible to continue protocol therapy at 8 months after diagnosis.;Secondary Objective: - CR rate after induction therapy - Overall survival (OS), Disease Free Survival (DFS) and the event-free survival (EFS) - Retrospective comparison of results versus patients with the same clinical characteristics registered in previous GIMEMA studies - Toxicity evaluation (grade III-IV events) of the Adriblastina and Dexamethasone re-induction phase - Treatment compliance in terms of dose intensity (drugs cumulative doses; interval therapy).;Primary end point(s): Feasibility evaluation - proportion of patients alive and in complete remission, still in study and eligible to continue it, 8 months after diagnosis - the following events will be considered: - grade III-IV toxicities implying an off-study event (both during induction phase Ia and Ib) and in the consolidation, including the high dose MTX - deaths - no-response after the induction phase - relapses

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Countries

Italy

Outcome results

None listed

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