NCT05367765Not yet recruitingPhase 4
A Real World Study of the Efficacy and Safety of Flumatinib Versus Imatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
Evaluating the Efficacy and Safety of Flumatinib Versus Imatinib for in Patients With Newly Diagnosed Chronic Myeloid Leukemia (CML)-in Chronic Phase (CP): A Multicenter, Open-label, Real World Study
Source: ClinicalTrials.gov · Last updated 10 May 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Flumatinib is an orally available TKI with high selectivity and potency against BCR-ABL1 kinase. It's a multi-center, open-label, real world study to explore the efficacy and safety of Flumatinib versus Imatinib as the first line therapy in patients with chronic myleiod leukemia(CML) in chronic phase(CP).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 2400 (estimated)
- First submitted
- 5 May 2022
- Start date
- 30 Apr 2022
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Diseases
- Chronic myeloid leukaemia
- NCT number
- NCT05367765
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 2400
- From 30 Apr 2022 to the primary completion date, 30 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with previously documented T315I mutation.
- Received BCR-ABL TKI(s) treatment before enrollment.
- Any treatment with anti-CML therapy over 2 weeks or hematopoietic stem cell transplantation before enrollment
Other
- Participated in other clinical trials that might affect the efficacy and safety of CML during this study.
- Pregnant or lactating female.
Who the study is looking for
- Men or women aged more than or equal to (≥) 18 years.
- Patients with Philadelphia chromosome positive chronic myelogenous leukemia in chronic phase (Ph+ CML-CP) within 6 months of diagnosis..
- Eastern Cooperative Oncology Group (ECOG) performance status: 0\~2.
- Signed and dated Informed Consent Form.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Hematology and Oncology, Harbin The First Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.