Treatment of FGFR1-rearranged neoplasms with Olverembatinib

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II study evaluates the efficacy of Olverembatinib, a third-generation tyrosine kinase inhibitor, in patients with FGFR1-rearranged myeloid/lymphoid neoplasms. These rare hematologic malignancies often have poor outcomes with conventional chemotherapy, and the only curative option is allogeneic hematopoietic stem cell transplantation (HSCT). The study aims to assess whether Olverembatinib can help achieve bone marrow remission in these patients, potentially serving as a bridge to HSCT or as an alternative for those ineligible for transplantation.

Why it matters

Who can join: the full rules

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.

Where it's running

• First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Suning Chen — First Affiliated Hospital of Soochow University
• Study coordinator: Suning Chen
• Email: chensuning@sina.com
• Phone: +86-13814881746

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.