Clinical trial · Interventional
Efficacy and Safety of Imatinib Mesylate as First-line Treatment for the Patients With Chronic Phase of Chronic Myeloid Leukemia
NCT02317159CI-TRIAL-00016335unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a efficacy and safety study of imatinib Mesylate Capsule as First line treatment in patients with chronic phase of Chronic Myeloid Leukemia.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib | Drug | Imatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- imatinib,Capsule
- description
- 400mg imatinib qd
- interventionNames
- Drug: Imatinib
Primary outcomes (1)
- measure
- major molecular response
- timeFrame
- 2 years
- description
- the rate of major molecular response in two years
Secondary outcomes (3)
- measure
- complete cytogenetics response
- timeFrame
- 1 years
- description
- the rate of complete cytogenetics response in one years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age≥18; * The new diagnosis of CML patients in six months; * No proof of extra-medullary infiltration of leukemia; * ECOG PS score:0-2; * Hepatic and renal functions are normal,Serum bilirubin≤1.5\*ULN, serum ALT and AST≤2.5\*ULN, serum Cr≤1.5\*ULN; * Do not receive the treatment of anti-CML; * Subjects signed informed consent form in line with GCP requirements。 Exclusion Criteria: * Pregnant or lactating women; * Received TKIs any time before; * Failure to control systemic infection or multiple organ failure; * According to the investigator's judgment, there are concomitant diseases with a serious safety hazard or affect the patients completed the study; * Being diagnosed with other malignancies in the prior 12 months; * Have a history of neurological or psychiatric disorders, including epilepsy or dementia; * Known or suspected allergy to imatinib; * BSA≤1.5m2; * Using other experimental drugs or participating in other clinical trials in the prior one months。
References
Publications (0)
Data not yet available
No reference posted for this study.