NCT01216085

Brief Summary

This study is locally amended study from CSTI571K2301 to evaluate the efficacy and safety of high-dose Glivec in Korean patients group with chronic phase of CML. Molecular response at 60 months after Glivec administration will be described.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_2

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, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 7, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

March 10, 2021

Status Verified

October 1, 2020

Enrollment Period

11 months

First QC Date

September 27, 2010

Last Update Submit

March 9, 2021

Conditions

CMLImatinib

Outcome Measures

Primary Outcomes (1)

  • Major molecular response

    Major molecular response achieved to Month 60 from the time of Glivec treatment

    60 months

Secondary Outcomes (2)

  • progression-free survival

    until 60 months

  • number of adverse events

    until 60 months

Study Arms (1)

imatinib

EXPERIMENTAL

Study patients will receive 400 mg twice daily oral administration in the morning and the evening.

Drug: high-dose imatinib

Interventions

high-dose imatinibDRUG

Study patients will receive 400 mg twice daily oral administration in the morning and the evening.

imatinib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • TOPS(CSTI571K2301) participant patients who are taking Glivec more than 400 mg daily as 30 July, 2010, the close date of TOPS
  • Patients who provided written informed consent prior to participation to this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigational Site

Seoul, 01008, South Korea

Location

MeSH Terms

Interventions

Imatinib Mesylate

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Dong-Wook Kim, MD, PhD

    Catholic Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2010

First Posted

October 7, 2010

Study Start

August 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

March 10, 2021

Record last verified: 2020-10

Locations

KR(1)