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Clinical Trials/EUCTR2009-016075-30-IT
EUCTR2009-016075-30-ITActive, not recruitingPhase 1

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

G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL`ADULTO0 sites30 target enrollmentStarted: July 20, 2010Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
30

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • ALL not-B mature, not Ph+ patients, phenotype line T (LLA-T) or B (LLA-B), aged =18 and <35 years (until 34 years and 364 days) and who have signed an informed consent in compliance with ICH-GCP and the applicable national laws.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • Age < 18 and =35 years - Patients who have performed a steroid pretreatment before being registered in the study - Patients who performed an antiblastic chemotherapic pretreatment - Patients with ALL-B mature (FAB L3, sIg+, TdT-) - Patinets with Biphenotypic Acute Leukemia (EGIL criteria) - Patients with t(9;22) ALL - Patients with a punctio sicca and peripherical blasts absence - Patients with Acute undifferentiated Leukemia - Patients with serum creatinine > 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.

Investigators

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

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