Clinical trial · Interventional
The Efficacy and Safety of Induction-Maintenance Protocol for Patients With Chronic Myelogenous Leukaemia
A Phase II Study to Determine the Efficacy and Safety of Induction-Maintenance Protocol for Patients With Chronic-Phase Chronic Myelogenous Leukaemia
- 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)
The purpose of this pilot study is to investigate whether some patients who were started on a 2G-TKI as first-line treatment can be safely switched to imatinib, a first-generation TKI, while maintaining or even deepening the molecular response as a cost-effective treatment. Eligible patients will be switched to imatinib 400mg daily, with regular molecular monitoring.
Conditions
Conditions (2)
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 |
| Philadelphia Chromosome Positive CML | Chronic Myeloid Leukemia, Philadelphia Chromosome Positive, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib Mesylate | Drug | Imatinib Mesylate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Imatinib Mesylate
- description
- imatinib 400mg daily
- interventionNames
- Drug: Imatinib Mesylate
Primary outcomes (1)
- measure
- molecular progression-free survival
- timeFrame
- 6 months
- description
- Molecular progression-free survival after switch to imatinib at 6 months
Secondary outcomes (6)
- measure
- molecular progression-free survival
- timeFrame
- 12 months
- description
- Molecular progression-free survival after switch to imatinib at 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult (aged 18 years or above) patients diagnosed with chronic-phase CML 2. Must have received a 2G-TKI (nilotinib or dasatinib) as first-line therapy for at least 12 months (Note: Cytoreductive agents, namely hydroxyurea and anagrelide, prior to the use of TKI are allowed.) 3. In sustained, good molecular response (i.e. molecular response (MR3) or below) for at least 6 months, as confirmed with at least 2 consecutive quantitative real time-polymerase chain reaction (RT-PCR) results Exclusion Criteria: 1. Under 18 years old 2. Adults under law protection or without ability to consent 3. Previous or planned autologous/allogeneic haematopoietic stem cell transplantation 4. Documented kinase domain mutation 5. A change to the current TKI because of unsatisfactory response to a previous TKI (Note: patients are still considered eligible if the switch in TKI was due to intolerance or side effects) 6. History of disease progression (accelerated or blast phase) 7. Patients who can speak neither Chinese nor English 8. Any molecular result during the preceding 6 months that is higher than MR3, i.e. BCR-ABL1/ABL1 ratio \>0.1% on IS ratio
References
Publications (0)
Data not yet available