NCT05521204RecruitingPhase 2
Olverembatinib for FGFR1-rearranged Neoplasms
A Study of Olverembatinib in the Treatment of Myeloid/Lymphoid Tumors With FGFR1 Rearrangement
Source: ClinicalTrials.gov · Last updated 30 Aug 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
FGFR1-rearranged myeloid/lymphoid neoplasms are a rare hematologic malignancy with very poor outcome despite intensive chemotherapy. The only curative option is thought to be allogeneic hematopoietic stem cell transplantation (HSCT) in remission. This phase II study is aimed to evaluate the efficacy of Olverembatinib, consolidated with HSCT in the treatment of FGFR1-rearranged myeloid/lymphoid neoplasm.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 27 Aug 2022
- Start date
- 1 Sept 2022
- Primary completion date
- 31 Aug 2024
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- NCT number
- NCT05521204
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 1 Sept 2022 to the primary completion date, 31 Aug 2024
- 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 who have received allogeneic hematopoietic stem cell or ponatinib.
Other illness
- Human immunodeficiency virus (HIV) infection, or chronic infection with hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive).
- Patients who suffer from any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the safety of the research drug.
Other
- Patients who are pregnant, planning to become pregnant or breastfeeding.
- Patients who may not be able to complete all study visits or procedures required by the study protocol, including follow-up visits, and/or fail to comply with all required study procedures.
Who the study is looking for
- Patients with newly diagnosed, progressed or relapsed myeloid/lymphoid neoplasms with FGFR1 rearrangement according to the WHO-2016 diagnostic criteria. Patients who have received allogeneic hematopoietic stem cell transplantation or ponatinib should be excluded.
- ECOG score: MPNs patients, 0-3 points; AL patients, 0-2 points.
- Expected survival period ≥12 weeks.
- Willingness and ability to comply with study procedures and follow-up examination.
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 |
|---|---|---|---|
| First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.