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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)

Primary Purpose

Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Nilotinib
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myelogenous Leukemia focused on measuring Chronic Myelogenous Leukemia, CML, Acute Lymphoblastic Leukemia, Philadelphia Chromosome Positive, ph+ ALL, Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive)

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who complete CAMN107A1101 and obtained Informed concent by document

Exclusion Criteria:

  • None

Sites / Locations

  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nilotinib

Arm Description

Outcomes

Primary Outcome Measures

Number of Adverse Events

Secondary Outcome Measures

Best hematologic response rate and Best cytogenetic response rate.
Percentage of BCR-ABL genes transcript and mutation status of BCR-ABL

Full Information

First Posted
December 2, 2010
Last Updated
December 6, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01279473
Brief Title
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)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia
Keywords
Chronic Myelogenous Leukemia, CML, Acute Lymphoblastic Leukemia, Philadelphia Chromosome Positive, ph+ ALL, Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nilotinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nilotinib
Other Intervention Name(s)
AMN107
Primary Outcome Measure Information:
Title
Number of Adverse Events
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Best hematologic response rate and Best cytogenetic response rate.
Time Frame
3 years
Title
Percentage of BCR-ABL genes transcript and mutation status of BCR-ABL
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who complete CAMN107A1101 and obtained Informed concent by document Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Aichi
Country
Japan

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4004
Description
Results from CAMN107A1101E1 can be found on the Novartis Clinical Trial Results Website

Learn more about this 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)

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