A multi-center, open label, non-controlled phase II study to evaluate efficacy and safety of oral nilotinib in pediatric patients with newly diagnosed Ph+ chronic myelogenous leukemia (CML) in chronic phase (CP) or with Ph+ CML in CP or accelerated phase (AP) resistant or intolerant to either imatinib or dasatinib

Phase 2

Completed

Conditions: Bloodcancer
proliferation of blood cells
10024324

Registration Number: NL-OMON47717

Lead Sponsor: ovartis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 3

Inclusion Criteria

1. Newly diagnosed and untreated Ph+ CML CP or Ph+ CML CP or AP resistant or intolerant to either imatinib or dasatinib;2. Karnofsky or Lansky * 50;3. Adequate renal, hepatic and pancreatic function;4. Potassium, magnesium, phosphorus and total calcium values * LLN (lower limit of normal);5. Written informed consent;Additional inclusion criteria are defined in the protocol.

Exclusion Criteria

1. Treatment with strong CYP3A4 inhibitors or inducers;2. Use or planned use of any medications that have a known risk or possible risk to prolong the QT interval;3. Acute or chronic liver, pancreatic or severe renal disease;4. History of pancreatitis or chronic pancreatitis.;5. Impaired cardiac function;6. No evidence of active graft vs host in less than 3 months since the last Stem Cell Transplant;7. Total body irradiation (TBI) or craniospinal radiation therapy in < 6months. Hypersensitivity to the active ingredient or any of the excipients including lactose;Additional exclusion criteria are defined in the protocol.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Rate of MCyR by 6 months<br /><br>* Rate of complete hematological response (CHR) by 3 months<br /><br>* Rate of MMR by 12 months by PCR analysis. MMR is defined as * 0.1%<br /><br>BCR-ABL/control gene % by international scale, measured by RQ-PCR which is<br /><br>equivalent to * 3 log reduction of BCR-ABL transcript from standardized<br /><br>* Rate of MCyR by 6 months</p><br>

Secondary Outcome Measures