Oral Nilotinib in Adults With Chronic Myeloid Leukemia (CML) in Blast Crisis Who Are Imatinib Resistant or Intolerant

Novartis

Status

Conditions: Chronic Myelogenous Leukemia

Treatments: Drug: nilotinib

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT00413270

CAMN107ACA01

Details and patient eligibility

About

This study will evaluate the safety of nilotinib in adult patients with imatinib-resistant or -intolerant CML-blast crisis, CML-accelerated phase or CML-chronic phase when treated with nilotinib. Patients will be provided access to nilotinib until the drug is available on the market.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Imatinib resistant or intolerant Philadelphia chromosome positive CML in blast crisis
• Imatinib resistant or intolerant Philadelphia chromosome positive CML in accelerated phase
• Imatinib resistant or intolerant Philadelphia chromosome positive CML in chronic phase
• CML patients who have been treated with an investigational tyrosine kinase inhibitor who otherwise meet the definition of imatinib resistance or intolerance
• World Health Organization (WHO) performance status ≤ 2

Exclusion criteria

• Cytopathologically confirmed central nervous system (CNS) infiltration
• Impaired cardiac function
• Use of therapeutic coumarin derivatives
• Acute chronic liver or renal disease unrelated to tumor
• Other uncontrolled medical conditions
• Treatment with hematopoeitic colony stimulating factors
• Treatment with medications that have potential to prolong the QT interval
• Another malignancy currently clinically significant or requires active intervention

Other protocol-defined inclusion/exclusion criteria may apply.