Olverembatinib for FGFR1-rearranged Neoplasms

NCT05521204 | Recruiting Phase 2 DMC

• 1 other identifier: SZ-FGFR1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myeloproliferative Neoplasm; Acute Leukemia

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  The proportion of participants who achieve Overall Response (ORR) based on response criteria for myeloid/lymphoid neoplasms with FGFR1 rearrangement

  Assessed at protocol-defined timepoints through end of study, up to approximately 48 months.

Secondary Outcomes (3)

• Event-free survival (PFS)

  From the first day of treatment until any failure (resistant disease, relapse, or death), assessed up to 2 to 4 years.

• Overall survival (OS)

  From the first day of treatment to time of death from any cause, assessed up 2 to 4 years.

• Incidence of adverse events (AEs)

  Up to approximately 2 to 4 years.

Study Arms (1)

Treatment Group

EXPERIMENTAL

Drug: Olverembatinib

Interventions

Olverembatinib DRUG

Given PO

Treatment Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Myeloproliferative Disorders

Interventions

olverembatinib

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Suning Chen

  First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suning Chen

CONTACT

+86-13814881746; chensuning@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 27, 2022
• First Posted: August 30, 2022
• Study Start: September 1, 2022
• Primary Completion: August 31, 2024
• Study Completion (Estimated): August 31, 2027
• Last Updated: August 30, 2022

Record last verified: 2022-08

Locations

CN (1)