NCT01279473

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 2, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
Last Updated

December 8, 2020

Status Verified

August 1, 2011

Enrollment Period

4.3 years

First QC Date

December 2, 2010

Last Update Submit

December 6, 2020

Conditions

Chronic Myelogenous LeukemiaAcute Lymphoblastic Leukemia

Keywords

Chronic Myelogenous LeukemiaCMLAcute Lymphoblastic LeukemiaPhiladelphia Chromosome Positive, ph+ ALLAcute Lymphoblastic Leukemia (Philadelphia Chromosome Positive)

Outcome Measures

Primary Outcomes (1)

  • Number of Adverse Events

    3 weeks

Secondary Outcomes (2)

  • 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

Study Arms (1)

Nilotinib

EXPERIMENTAL
Drug: Nilotinib

Interventions

NilotinibDRUG
Also known as: AMN107
Nilotinib

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who complete CAMN107A1101 and obtained Informed concent by document

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Aichi, Japan

Location

Related Links

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL PositivePrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

nilotinib

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2010

First Posted

January 19, 2011

Study Start

August 1, 2005

Primary Completion

December 1, 2009

Last Updated

December 8, 2020

Record last verified: 2011-08

Locations

JP(1)