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Discontinuation Study of Imatinib in Adult CP CML Patients Who Have a Complete Molecular Response to Imatinib

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ClinicalTrials.gov Identifier: NCT01564836
Recruitment Status : Unknown
Verified January 2014 by Dong-Wook Kim, Seoul St. Mary's Hospital.
Recruitment status was:  Recruiting
First Posted : March 28, 2012
Last Update Posted : January 13, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment
Chronic Myeloid Leukemia Imatinib Complete Molecular Response Behavioral: Imatinib treatment discontinuing

Detailed Description:

Imatinib (IM) treatment has been the standard of care for chronic phase (CP) chronic myeloid leukemia (CML) and approximately 50% of CP CML patients who received IM treatment achieve complete molecular response (CMR) at 6-7 years.(Hochhaus A et al. Leukemia 2009;23:1054-1061, Hughes et al. Blood 2008;112:334) The recent data from a study aimed to assess whether IM can be discontinued in patients with a CMR lasting at least 2 years showed the probability of persistent CMR at 12 months was 41%, and suggested IM can be safely discontinued, at least in some patients with sustained CMR. (Mahon et al. Lancet Oncol 2010;11:1029-1035) However, to define whether discontinuation of IM treatment can be safely employed, further validation and much longer follow-up are needed.

Aims This prospective study is performed to identify safer and more concrete indicators of successful discontinuation and explore contributing factors for sustained undetectable transcript.

Primary Objective:

  • 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
  • To identify contributing factors for sustained undetectable transcript

Secondary Objective:

  • To evaluate the probability of major molecular response (MMR) loss
  • To evaluate the time taken to lose MMR at 12 months after discontinuation
  • In patients with loss of MMR, the probability of re-achieving MMR/MR4.5
  • To measure the time taken to re-achieve MMR/MR4.5 after IM resumption
  • To identify contributing factors for sustained re-achieve MMR/MR4.5

Trial Design This is a prospective, multicenter, non-randomised IM discontinuation study.

Response Evaluation After discontinuation, molecular response was monitored using RQ-PCR assay every month up to 6 month follow-up, every 2 months up to 12 month follow-up, and every 3 months thereafter. The loss of MMR, MR4.5, and UMRD were defined on 2 consecutive assessments.

If loss of MMR occurred, IM treatment was re-introduced. Written informed consents were obtained for all patients


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2010
Estimated Primary Completion Date : June 2015


Arms and Interventions

Arm Intervention/treatment
Experimental: Imatinib treatment discontinuing Behavioral: Imatinib treatment discontinuing
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


Outcome Measures

Primary Outcome Measures :
  1. Probability of persistent undetectable molecular residual disease (UMRD) and MR4.5 [ Time Frame: 12 months ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564836


Contacts
Contact: Sahee Park, MS +82-2-2258-7030 saheepark@catholic.ac.kr

Locations
Korea, Republic of
Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 137-701
Contact: Sahee Park, MS    +82-2-2258-7030    saheepark@catholic.ac.kr   
Principal Investigator: Dong-Wook Kim, Professor         
Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
Seoul St. Mary's Hospital
Ministry of Health & Welfare, Korea
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dong-Wook Kim, Professor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT01564836     History of Changes
Other Study ID Numbers: KC10ENME0465
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: January 13, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action