Treatment of FGFR1-rearranged neoplasms with Olverembatinib

A Study of Olverembatinib in the Treatment of Myeloid/Lymphoid Tumors With FGFR1 Rearrangement

This study is testing if a new drug called Olverembatinib can help people with rare blood cancers caused by FGFR1 changes get better and possibly prepare them for a stem cell transplant.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Drugs / interventions: ponatinib, Olverembatinib, chemotherapy
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT05521204 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients with newly diagnosed, progressed, or relapsed myeloid/lymphoid neoplasms that have FGFR1 rearrangement.

Not a fit: Patients who have previously received allogeneic HSCT or ponatinib, as well as those with certain viral infections or who are pregnant, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with FGFR1-rearranged neoplasms, improving their chances of remission and survival.

How similar studies have performed: While there is limited data on the specific use of Olverembatinib for this indication, the approach of using targeted therapies in hematologic malignancies has shown promise in other studies.

Eligibility 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.

Where this trial is running

Suzhou, Jiangsu

• 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

Conditions Myeloproliferative Neoplasm; Acute Leukemia