Olverembatinib for FGFR1-rearranged Neoplasms

• Status: Recruiting
• Trial end date: 2027-08-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Soochow University

Criteria

Inclusion Criteria:

1. 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.

2. ECOG score: MPNs patients, 0-3 points; AL patients, 0-2 points.

3. Expected survival period ≥12 weeks.

4. Willingness and ability to comply with study procedures and follow-up examination.

Exclusion Criteria:

1. Patients who have received allogeneic hematopoietic stem cell or ponatinib.

2. Human immunodeficiency virus (HIV) infection, or chronic infection with hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive).

3. Patients who are pregnant, planning to become pregnant or breastfeeding.

4. 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.

5. 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.