Clinical trial · Expanded Access
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
NCT00413270CI-TRIAL-00005205no longer availableClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nilotinib | Drug | Nilotinib | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.