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)

Phase 1

Completed

• Conditions: Acute Lymphoblastic Leukemia; Chronic Myelogenous Leukemia
• Interventions: Drug: Nilotinib

• Registration Number: NCT01279473
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study will investigate if nilotinib provides an improved safety and efficacy profile over that seen in patients receiving Imatinib.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Primary Completion: 2009-12
• Study First Submitted: 2010-12-02
• Study First Submitted QC: 2011-01-18
• Study First Posted: 2011-01-19
• Status Verified: 2011-08
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Patients who complete CAMN107A1101 and obtained Informed concent by document

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nilotinib	Nilotinib	-

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	3 weeks

Secondary Outcome Measures

Name	Time	Method
Best hematologic response rate and Best cytogenetic response rate.	3 years
Percentage of BCR-ABL genes transcript and mutation status of BCR-ABL	3 years

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Aichi, Japan