Clinical trial · Interventional
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+)
NCT01222013CI-TRIAL-00009819suspendedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was suspended before recruitment, due to logistic issues.
Summary
Brief summary (as posted)
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+.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+) | Poroid Hidradenoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib Mesylate | Drug | Imatinib Mesylate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Imatinib Mesylate
- interventionNames
- Drug: Imatinib Mesylate
Primary outcomes (1)
- measure
- 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+.
- timeFrame
- Up to 24 months.
- description
- 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 outcomes (1)
- measure
- Evaluate toxicity and tolerability in the administration of Imatinib in conjunction with chemotherapy in children with ALL Ph+.
- timeFrame
- Up to 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.