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NCT01279473 Clinical Trial

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)

Acute Lymphoblastic Leukemia Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01279473
Other study ID # CAMN107A1101E1
Secondary ID TAS-3-01
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date August 2005

Study information
Verified date August 2011
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - Patients who complete CAMN107A1101 and obtained Informed concent by document Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Nilotinib

Locations
Country Name City State
Japan Novartis Investigative Site Aichi

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Adverse Events 3 weeks
Secondary Best hematologic response rate and Best cytogenetic response rate. 3 years
Secondary Percentage of BCR-ABL genes transcript and mutation status of BCR-ABL 3 years
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