Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

Phase 4

Completed

• Conditions: Chronic Myeloid Leukemia
• Interventions: Drug: Nilotinib

• Registration Number: NCT00786812
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the \[CAMN107A2109\] study

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-11-05
• Study First Submitted QC: 2008-11-05
• Study First Posted: 2008-11-06
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AMN107 Naive	Nilotinib	-
CAMN107A2109 Extension Patients	Nilotinib	-

Primary Outcome Measures

Name	Time	Method
Disease response (complete hematologic response, cytogenetic response) and progression at or until 24 months, depending of the case every 3 months	3 - 24 months

Trial Locations

Locations (1)

Novartis Investigative Site; 🇧🇷 São Paulo, SP, Brazil