Clinical trial · Interventional
Study to Evaluate Nilotinib in Adult Patients With Imatinib-resistant or Imatinib-intolerant Chronic Myelogenous Leukemia (CML), or Relapse/Refractory Ph+ Acute Lymphoblastic Leukemia (ALL) (Extension Study)
A Phase I/II Multicenter, Dose-escalation Study of Oral Nilotinib on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant or Imatinib-intolerant Chronic Myelogenous Leukemia (CML), or Relapse/Refractory Ph+ALL (Philadelphia Positive Acute Lymphocytic Leukemia)(Extension Study)
NCT01279473CI-TRIAL-00048706completedPhase 1 / Phase 2ClinicalTrials.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 investigate if nilotinib provides an improved safety and efficacy profile over that seen in patients receiving Imatinib.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Chronic Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
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
- Number of Adverse Events
- timeFrame
- 3 weeks
Secondary outcomes (2)
- measure
- Best hematologic response rate and Best cytogenetic response rate.
- timeFrame
- 3 years
- measure
- Percentage of BCR-ABL genes transcript and mutation status of BCR-ABL
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who complete CAMN107A1101 and obtained Informed concent by document Exclusion Criteria: * None
References
Publications (0)
Data not yet available
No reference posted for this study.