Clinical trial · Interventional
Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
An Open-label, Multicenter Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
NCT00786812CI-TRIAL-00026096MACS0439completedPhase 4ClinicalTrials.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)
Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the \[CAMN107A2109\] study
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 Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nilotinib | Drug | Nilotinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- CAMN107A2109 Extension Patients
- interventionNames
- Drug: Nilotinib
- type
- OTHER
- label
- AMN107 Naive
- interventionNames
- Drug: Nilotinib
Primary outcomes (1)
- measure
- Disease response (complete hematologic response, cytogenetic response) and progression at or until 24 months, depending of the case every 3 months
- timeFrame
- 3 - 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. patients currrently participating in Novartis study CAMN107A2109 2. imatinib - resistant or intolerant - Philadelphia chromosome-positive CML in chronic (CML-CP)accelerated phase (CML-AP) or in blast crisis (CML-BC) 3. males or females ≥18 years of age 4. WHO Performance Status of ≤ 2 5. patients must have the following laboratory values: ALT and AST ≤ 2.5 x ULN or ≤ 5.0 x ULN if considered due to tumor Exclusion Criteria: 1. Impaired cardiac function; use of therapeutic coumarin derivatives 2. patients who have undergone a major surgery and have not recovered from side effects of such therapy within 15 days 3. patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control 4. patients who have received chemotherapy ≤ 1 week or who are within 5 half-lives of their last dose of chemotherapy 5. ,.patients who have received imatinib or dasatinib at least 3 days prior to beginning of study drug or who have not recovered from side effects of such therapy
References
Publications (0)
Data not yet available
No reference posted for this study.