EUCTR2004-001647-30-IT
Active, not recruiting
Phase 1
An open-label study to evaluate the safety and efficacy of IMATINIB with chemotherapy in pediatric patients with Ph+/BCR-ABL+ acute lymphoblastic leukemia (Ph+ALL) - EsPhA
A.I.E.O.P. - ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA0 sites550 target enrollmentDecember 4, 2012
ConditionsChildren and adolescents aged 1-17 years at diagnosis, with Ph+ALLMedDRA version: 14.1Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsGLIVEC*120CPS 100MG
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Children and adolescents aged 1-17 years at diagnosis, with Ph+ALL
- Sponsor
- A.I.E.O.P. - ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA
- Enrollment
- 550
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Children and adolescents aged 1\-17 years at diagnosis, with Ph\+ALL documented by either cytogenetics , PCR or FISH for bcr\-abl, who are eligible for the current local prospective therapeutic study of childhood ALL and for whom informed consent was given by the parents or by legal guardian.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 600
- •F.1\.2 Adults (18\-64 years) no
- •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
- •1\.Abnormal hepatic function (ALAT/ASAT \> 10 times the upper limit of the normal range); 2\.Abnormal renal function ( creatinine \> 1\.5 times the upper limit of the normal range or a calculated creatinine clearance of 80ml/ min or less, adjusted to a body surface area of 1\.73 sqm); 3\.Active systemic bacterial, fungal or viral infection as documented by positive cultures, radiological imaging techniques, septic shock symptoms
Outcomes
Primary Outcomes
Not specified
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