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

NCT02204722 | Terminated Phase 4

• 1 other identifier: IMA_CML_IV
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• MMR rate at 12 months in two groups

  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.

  12 months

Secondary Outcomes (6)

• CCyR in group A and B

  12 months

• MMR in group A and B

  12 months

• CMR in group A and B

  12 months

• Survival rate in group A and B

  12 months

• Progression rate to AP/BC in group A and B

  12 months

Study Arms (2)

Group B

EXPERIMENTAL

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

Group A

EXPERIMENTAL

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

Interventions

600mg/day of Imatinib DRUG

Group B

400mg/day of Imatinib DRUG

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead
• SeoulCRO: collaborator

Study Sites (1)

Asan Medical Center

Seoul, 138736, South Korea

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• 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 Ansan Hospital

  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 Haeundae Paik Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: July 30, 2014
• Study Start: October 13, 2014
• Primary Completion: May 23, 2017
• Study Completion: January 9, 2018
• Last Updated: June 15, 2018

Record last verified: 2018-06

Locations

KR (1)