Status:
SUSPENDED
Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)
Lead Sponsor:
Renato Melaragno
Conditions:
Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)
Eligibility:
All Genders
1-18 years
Phase:
PHASE2
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 chil...
Eligibility Criteria
Inclusion
- 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.
- 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.
- Life expectation \> 8 weeks.
- Medications: antineoplastic treatment-naïve, including corticotherapy, except for patients that performed Induction for ALL (33 days) exactly as this protocol.
- Signed ICF by child legal responsible.
- 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
- Any inclusion criteria missing.
- Pregnant patient or breastfeeding.
- Patient considered incapable to follow purposed treatment.
- Subject with infectious process, in activity, grade IV.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01222013
Last Update
March 26 2013
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