Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+) Clinical Trial
Official title:
Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)
| NCT number | NCT01222013 |
| Other study ID # | CSTI571ABR22T |
| Secondary ID | |
| Status | Suspended |
| Phase | Phase 2 |
| First received | October 15, 2010 |
| Last updated | March 25, 2013 |
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+.
| Status | Suspended |
| Enrollment | 20 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 1 Year to 18 Years |
| Eligibility |
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 ßhCG) 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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Renato Melaragno |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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+. | 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. | Up to 24 months. | No |
| Secondary | Evaluate toxicity and tolerability in the administration of Imatinib in conjunction with chemotherapy in children with ALL Ph+. | 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. |
Up to 24 months | Yes |