Acute Leukemia Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | August 31, 2027 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | First Affiliated Hospital of Soochow University | Suzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Soochow University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Event-free survival (PFS) | The Kaplan-Meier method will be used to assess EFS probabilities. | From the first day of treatment until any failure (resistant disease, relapse, or death), assessed up to 2 to 4 years. | |
Secondary | Overall survival (OS) | The Kaplan-Meier method will be used to assess OS probabilities. | From the first day of treatment to time of death from any cause, assessed up 2 to 4 years. | |
Secondary | Incidence of adverse events (AEs) | Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. The proportion of patients with AEs will be estimated, along with the Bayesian 95% credible interval. | Up to approximately 2 to 4 years. |
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