Discontinuation Study of Imatinib in Adult CP CML Patients Who Have a Complete Molecular Response to Imatinib
A Multi-center Study of the Discontinuation of Imatinib in Adult Patients With Ph+ CML in CP Who Have a Complete Molecular Response to Imatinib
1 other identifier
interventional
50
1 country
2
Brief Summary
This prospective study is performed to identify safer and more concrete indicators of successful discontinuation and explore contributing factors for sustained undetectable transcript
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 26, 2012
CompletedFirst Posted
Study publicly available on registry
March 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedJanuary 13, 2014
January 1, 2014
5 years
March 26, 2012
January 10, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Probability of persistent undetectable molecular residual disease (UMRD) and MR4.5
Our primary objectives were to evaluate the probability of persistent undetectable molecular residual disease (UMRD) and MR4.5 at 12 months after discontinuation, to measure the duration of persistent UMRD and MR4.5 after discontinuation, and to identify contributing factors for sustained undetectable transcript.
12 months
Study Arms (1)
Imatinib treatment discontinuing
EXPERIMENTALInterventions
Ph+ CP CML patients who were treated with IM for more than 3 years in sustained MR4.5 or undetectable transcript for at least 2 years are enrolled
Eligibility Criteria
You may qualify if:
- Adult (≥ 18 years-old) Ph+ CP CML patients who were treated with IM for more than 3 years in sustained MR4.5 or undetectable transcript for at least 2 years are enrolled. MR4.5 or undetectable transcript must be sustained by 2 consecutive RQ-PCR assay within 6 months
You may not qualify if:
- Patients were diagnosed with AP or BP CML
- Ph+ ALL
- Received cytotoxic chemotherapy or any other TKIs except imatinib
- Any evidence of on-going graft versus-host disease (GVHD)
- Relapsed patients after allogeneic stem cell transplantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul St. Mary's Hospitallead
- Ministry of Health & Welfare, Koreacollaborator
Study Sites (2)
Seoul St. Mary's Hospital
Seoul, 137-701, South Korea
Seoul St. Mary's Hospital
Seoul, 137-701, South Korea
Related Publications (1)
Lee SE, Choi SY, Song HY, Kim SH, Choi MY, Park JS, Kim HJ, Kim SH, Zang DY, Oh S, Kim H, Do YR, Kwak JY, Kim JA, Kim DY, Mun YC, Lee WS, Chang MH, Park J, Kwon JH, Kim DW. Imatinib withdrawal syndrome and longer duration of imatinib have a close association with a lower molecular relapse after treatment discontinuation: the KID study. Haematologica. 2016 Jun;101(6):717-23. doi: 10.3324/haematol.2015.139899. Epub 2016 Feb 17.
PMID: 26888022DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 26, 2012
First Posted
March 28, 2012
Study Start
June 1, 2010
Primary Completion
June 1, 2015
Last Updated
January 13, 2014
Record last verified: 2014-01