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

A Canadian Open-label, Multicenter, Expanded Access Study of Oral Nilotinib in Adult Patients With Imatinib-resistant or -Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase, or Chronic Phase

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT00413270
Enrollment
Unknown
Registered
2006-12-19
Start date
2006-12-31
Completion date
Unknown
Last updated
2011-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myelogenous Leukemia

Keywords

Imatinib resistant,, Imatinib intolerant,, CML- blast crisis,, CML- Accelerated phase,, CML- chronic phase,, nilotinib,, Chronic myelogenous leukemia,, blast crisis,, accelerated phase,, chronic phase

Brief summary

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.

Interventions

DRUGnilotinib

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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/

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026