Tests olverembatinib in people with FGFR1-rearranged blood cancers
Tests olverembatinib, alongside stem cell transplant, in people with FGFR1-rearranged blood cancer.
Plain-language title generated from the registry record
Registry title: Olverembatinib for FGFR1-rearranged Neoplasms
Key facts
- Where
- Suzhou, ChinaSee the site
- Phase
- Phase 2
Where in China
- First Affiliated Hospital of Soochow UniversitySuzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The First Affiliated Hospital of Soochow University
- Trial code
- NCT05521204
- Record updated
- 30 August 2022
- Original description
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.Read full original descriptionShow less
A Study of Olverembatinib in the Treatment of Myeloid/Lymphoid Tumors With FGFR1 Rearrangement
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.
Inclusion: 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.
Exclusion: Patients who have received allogeneic hematopoietic stem cell or ponatinib; 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; 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.