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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)

NCT ID: NCT01279473

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Brief Summary

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

Detailed Description

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Conditions

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Chronic Myelogenous Leukemia Acute Lymphoblastic Leukemia

Keywords

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Chronic Myelogenous Leukemia CML Acute Lymphoblastic Leukemia Philadelphia Chromosome Positive, ph+ ALL Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nilotinib

Group Type EXPERIMENTAL

Nilotinib

Intervention Type DRUG

Interventions

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Nilotinib

Intervention Type DRUG

Other Intervention Names

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AMN107

Eligibility Criteria

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Inclusion Criteria

* Patients who complete CAMN107A1101 and obtained Informed concent by document

Exclusion Criteria

* None
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Aichi, , Japan

Site Status

Countries

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Japan

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4004

Results from CAMN107A1101E1 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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TAS-3-01

Identifier Type: -

Identifier Source: secondary_id

CAMN107A1101E1

Identifier Type: -

Identifier Source: org_study_id