Clinical trial · Interventional
A Study of 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
NCT01126892CI-TRIAL-00026195ENACTcompletedPhase 3ClinicalTrials.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)
A multicenter, open label study of Nilotinib in CML patients PH + with imatininb resistant in blast crisis, accelerated phase or chronic phase. The main purpose is evaluate the safety and efficacy of Nilotinib.
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 (1)
- type
- EXPERIMENTAL
- label
- Nilotinib
- interventionNames
- Drug: Nilotinib
Primary outcomes (1)
- measure
- Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the CAMN107A2109 study.
- timeFrame
- between 6 and 12 months
Secondary outcomes (3)
- measure
- To evaluate the rate of any durable cytogenetic response and Complete cytogenetic response
- timeFrame
- 24 months
- measure
- To evaluate the rate of molecular response every 3 months, until 24th month of treatment or end of study
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Stratum 1: 1. Currently participating in Novartis study CAMN107A2109 2. Written signed and dated informed consent prior to any study procedures being performed Stratum 2: 1. Male or female 2. \> 18 years 3. ECOG 0,1,2 4. ASL/ALT \<= 2.5 ULN or \<= 5.0 ULN 5. Alcaline Phosfatase \<= 2.5 ULN 6. Serum Bilirrubin \<= 1.5 ULN 7. Serum Creatinine \<= 1.5 ULN or creatinine clearance \>=50 ml/min / 24 hours 8. Serum Lipase \<= 1.5 ULN Exclusion Criteria: Stratum 1 and stratum 2: 1. Reduction of the cardiac function 2. Use of Coumadin 3. Other severe medical concurrent conditions 4. Treatment with medications that prolonged the QT interval. 5. Mayor surgery 15 days before the inclusion in the protocol 6. Pregnant women or lactation Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.