Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Chronic Myeloid Leukemia (CML) Philadelphia Chromosome-positive (Ph+)
This trial is active, not recruiting.
|Condition||chronic myeloid leukemia (cml) with philadelphia chromosome-positive (ph+)|
|Start date||February 2011|
|End date||June 2013|
|Trial size||20 participants|
|Trial identifier||NCT01221376, CSTI571ABR23T|
The purpose of this study is to evaluate the hematological, cytogenetic and molecular response to continuous-use of Imatinib in children with CML Ph+.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Evaluate the complete cytogenetic response with continuous-use of Imatinib.
time frame: Up to 12 months
Evaluate the response to continuous-use of Imatinib and the toxicity and tolerability in children with CML Ph+.
time frame: Up to 24 months
Male or female participants up to 18 years old.
- Diagnose: suspected CML (hematology and/or myelogram and/or immunophenotyping and/or Leukocyte alkaline phosphatase [LAP]) to be confirmed, after, by cytogenetic and/or molecular biology. OBS: only CML Ph+ newly-diagnose in chronic or accelerate phase; resistant CML Ph+ to Interferon α (INF-α), Hydroxyurea and/or low-dose ARA-C in chronic or accelerate phase; CML Ph+ with cytogenetic relapse after BMT, that didn't use Imatinib previously, in chronic or accelerate phase.
- Female patients of childbearing age, should have pregnancy test (blood βhCG) performed before treatment initiation. Effective contraception must be used. Pregnant women won't be included.
- Karnofsky and Lansky scale: ≥40.
- Life expectation > 8 weeks.
- 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 < 3 x ULN and albumin > 2 g/dl.
- CNS toxicity ≤ II
- Cardiac function: normal ejection fraction.
- Signed ICF by child legal responsible.
- Patient receiving any other tyrosine kinase inhibitor (TKI).
- Pregnant patient or breastfeeding.
- Patient considered incapable to follow purposed treatment.
- Patients with molecular relapsed.
- Colony stimulating: it cannot be administered at least 1 week before treatment.
- Anticonvulsants: Imatinib is metabolized by P-450 enzyme, thereby subject cannot receive drug that activates the P-450 system. The anticonvulsants allowed are valproic acid and benzodiazepines.
- Anticoagulants: The use of warfarin (Marevan) is not allowed. If anticoagulant is needed, low-molecular-weight heparin (LMWH) can be used. Avoid anticoagulants with platelets < 50000.
- INF-Α 48h before D1.
- Hydroxyurea 24h before D1.
- ARA-C doses >100 mg/m2 for 5-7 days, 14 days before D1.
- Anthracyclines, Mitoxantrone or Etoposide 21 days before D1.
- Any other chemotherapeutic agent 28 days before D1.
- Hematopoietic Cell Transplantation (HCT) 6 weeks before D1.
|Official title||Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Chronic Myeloid Leukemia (CML) Philadelphia Chromosome-positive (Ph+)|
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