Clinical trial · Interventional
A Study to Evaluate Efficacy and Safety of Glinib in Newly Diagnosed CML Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor's decision to halt the study.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 400mg/day of Imatinib | Drug | — | UNRESOLVED |
| 600mg/day of Imatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group B
- description
- 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.
- interventionNames
- Drug: 600mg/day of Imatinib
- type
- EXPERIMENTAL
- label
- Group A
- description
- 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.
- interventionNames
- Drug: 400mg/day of Imatinib
Primary outcomes (1)
- measure
- MMR rate at 12 months in two groups
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available