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A Study to Evaluate Efficacy and Safety of Glinib in Newly Diagnosed CML Patients (IDEAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02204722
Recruitment Status : Terminated (Sponsor's decision to halt the study.)
First Posted : July 30, 2014
Last Update Posted : June 15, 2018
Sponsor:
Collaborator:
SeoulCRO
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

Brief Summary:
This study is to evaluate efficacy and safety of Imatinib in two groups of patients; all patients should be diagnosed less than 3 months as chronic myeloid leukemia in a chronic phase. The group A, the reference group, will have 10% or less than 10% of the BCR-ABL level after three month dosing and be maintained their dose of 400mg/day. On the other hand, the group B, will have more than 10% and the dose will be increased from 400mg/day to 600mg/day. The superiority of the group B will be proved by evaluating the MMR rate of these two groups after 12 months of administeration of Imatinib.

Condition or disease Intervention/treatment Phase
Chronic Myeloid Leukemia Drug: 600mg/day of Imatinib Drug: 400mg/day of Imatinib Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IV Study to Evaluate Efficacy and Safety of Imatinib(Glinib®) 600mg/Day Depending on Early Molecular Response in Newly Diagnosed Patients With Chronic Myeloid Leukemia in Chronic Phase
Actual Study Start Date : October 13, 2014
Actual Primary Completion Date : May 23, 2017
Actual Study Completion Date : January 9, 2018


Arm Intervention/treatment
Experimental: Group B
the group who has more than 10% of the BCR-ABL(IS) level for three months will receive 600mg/day of Imatinib after three months.
Drug: 600mg/day of Imatinib
Experimental: Group A
the group who has more than 10% of the BCR-ABL(IS) level for three months will maintain the dose, 400mg/day of Imatinib, after three months.
Drug: 400mg/day of Imatinib



Primary Outcome Measures :
  1. MMR rate at 12 months in two groups [ Time Frame: 12 months ]
    MMR rate at 12 months in two groups will be compared. Group A is consisted of patients with equal or less than 10% of BDR-ABL, Group B is consisted of patients with more than 10% of BDR-ABL.


Secondary Outcome Measures :
  1. CCyR in group A and B [ Time Frame: 12 months ]
    CCyR rate for 12 months and the duration of the complete CCyR will be evaluated.

  2. MMR in group A and B [ Time Frame: 12 months ]
    MMR rate for 12 months and the duration of MMR will be measured.

  3. CMR in group A and B [ Time Frame: 12 months ]
  4. Survival rate in group A and B [ Time Frame: 12 months ]
  5. Progression rate to AP/BC in group A and B [ Time Frame: 12 months ]
  6. the actual administration [ Time Frame: 12 months ]
    the total dose will be divided by total days of the treatment.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • at the age of 18 or more
  • newly diagnosed within three months as a Chronic Myeloid Leukemia
  • with positive Philadelphia chromosome and appearance of BCR-ABL transcript
  • with 0 - 2 of ECOG Performance Status
  • with normal renal function
  • with normal hepatic function
  • able to understand and decide to involve the study

Exclusion Criteria:

  • history of radiation therapy for more than 25% of bone marrow due to other malignant diseases
  • history of other clinically relevant malignant tumors
  • with bleeding disorders which are not related to leukemia
  • evidence of clinically relevant cardiac dysfunction
  • with severe disease which cannot be regulated by other organs
  • a previous administration of Imatinib more than a week prior to the first dose.
  • participation in other drug study(eg. intervention trial) within 30 days prior to the screening visit
  • HIV-infected
  • females with pregnancy, childbearing or lactating potential
  • other reasons determined by investigators

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): NCT02204722


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138736
Sponsors and Collaborators
Dong-A ST Co., Ltd.
SeoulCRO
Investigators
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Principal Investigator: Kyu-Hyoung Lee, M.D. Asan Medical Center
Principal Investigator: Jin-hee Park, M.D. Gachon University Gil Medical Center
Principal Investigator: Chul-won Choi, M.D. Korea University Guro Hospital
Principal Investigator: Sae-ryun Lee, M.D. Korea University
Principal Investigator: Yong Park, M.D. Korea University Anam Hospital
Principal Investigator: Joo-sup Joeng, M.D. Pusan National University Hospital
Principal Investigator: Jung-ok Lee, M.D. Seoul National University Bundang Hospital
Principal Investigator: Chul-won Jung, M.D. Seoul Medical Center
Principal Investigator: Sung-soo Yoon, M.D. Seoul National University Hospital
Principal Investigator: Kyung-ha Kim, M.D. Soonchunhyang University Hospital Seoul
Principal Investigator: Joon-sung Park, M.D. Ajou University School of Medicine
Principal Investigator: Duk-yeon Cho, M.D. Chungnam National University Hospital
Principal Investigator: Sung-nam Im, M.D. Inje University

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Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT02204722    
Other Study ID Numbers: IMA_CML_IV
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
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