Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)

Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)

Status

Suspended

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01222013

Enrollment

Registered

2010-10-18

Start date

Unknown

Completion date

Unknown

Last updated

2013-03-26

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

Conditions

Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)

Brief summary

The purpose of this study is to evaluate the efficacy, through molecular response and event-free survival, about the use of Imatinib in conjunction with chemotherapy after BFM like Induction in children with ALL Ph+.

Interventions

DRUGImatinib Mesylate

patient will receive Imatinib (Glivec®), 300 mg/m²/day, per oral, in conjunction with chemotherapy, maximum dose allowed 400 mg/dia.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

Healthy volunteers

Inclusion criteria

1. Diagnose: therapy-naïve ALL, except for patients that performed Induction for ALL (33 days) exactly as this protocol and; documented Ph+, to be confirmed by conventional cytogenetic - t(9;22) (q34;q11) or FISH and/or gene BCR-ABL presence by RT-PCR or FISH. 2. Female patients of childbearing age, should have pregnancy test (blood βhCG) performed before treatment initiation. Effective contraception must be used during treatment. Pregnant women won't be included. 3. Life expectation \> 8 weeks. 4. Medications: antineoplastic treatment-naïve, including corticotherapy, except for patients that performed Induction for ALL (33 days) exactly as this protocol. 5. Signed ICF by child legal responsible. 6. Laboratory: renal function (serum creatinine ≤ 1,5 x ULN and/or Clearance ≥70 ml/min/1,73m2), hepatic function (total bilirubin ≤ 1,5 x ULN, TGP/TGO \< 10 x ULN and albumin \> 2 g/dl.

Exclusion criteria

1. Any inclusion criteria missing. 2. Pregnant patient or breastfeeding. 3. Patient considered incapable to follow purposed treatment. 4. Subject with infectious process, in activity, grade IV.

Design outcomes

Primary

Measure	Time frame	Description
Evaluate the efficacy, through molecular response and event-free survival, about the use of Imatinib in conjunction with chemotherapy after BFM like Induction in children with ALL Ph+.	Up to 24 months.	Cytogenetic and molecular response will be evaluate at the end of Induction I (D33), before each consolidation block (HR 1, 2 and 3), before re-induction, before maintenanceand at the end of therapy.

Secondary

Measure	Time frame	Description
Evaluate toxicity and tolerability in the administration of Imatinib in conjunction with chemotherapy in children with ALL Ph+.	Up to 24 months	Toxicity and tolerability will be verified in every visit according through: * Adverse events during the study. * Laboratory exams. * Vital signs and body weight. * Physical evaluation. * Concomitant medication.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026