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Olverembatinib for FGFR1-rearranged Neoplasms

Primary Purpose

Myeloproliferative Neoplasm, Acute Leukemia

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Olverembatinib
Sponsored by
The First Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myeloproliferative Neoplasm

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • First Affiliated Hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Event-free survival (PFS)
The Kaplan-Meier method will be used to assess EFS probabilities.
Overall survival (OS)
The Kaplan-Meier method will be used to assess OS probabilities.
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.

Full Information

First Posted
August 27, 2022
Last Updated
August 27, 2022
Sponsor
The First Affiliated Hospital of Soochow University
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1. Study Identification

Unique Protocol Identification Number
NCT05521204
Brief Title
Olverembatinib for FGFR1-rearranged Neoplasms
Official Title
A Study of Olverembatinib in the Treatment of Myeloid/Lymphoid Tumors With FGFR1 Rearrangement
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Soochow University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
FGFR1-rearranged myeloid/lymphoid neoplasms are a rare and highly heterogeneous hematological malignancy, mainly manifested as myeloproliferative neoplasms (MPNs) or acute leukemia, including T cells or B cells Cell lymphoblastic leukemia/lymphoma (T-cell or B-cell-ALL/LBL), acute myeloid leukemia (AML) and mixed cell leukemia (MPAL). To date, there is no standard treatment. Conventional chemotherapy is frequently ineffective. The only curative option is thought to be allogeneic HSCT at present, TKIs may offer a therapeutic alternative in patients not eligible for allogeneic HSCT or to bridge the time between diagnosis and allogeneic HSCT. Third-generation TKIs Olverembatinib is a pan- FGFR1 kinase inhibitor, and is supposed to be effective to achieve bone marrow remission in FGFR1-rearranged myeloid/lymphoid neoplasms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myeloproliferative Neoplasm, Acute Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Olverembatinib
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
The proportion of participants who achieve Overall Response (ORR) based on response criteria for myeloid/lymphoid neoplasms with FGFR1 rearrangement
Time Frame
Assessed at protocol-defined timepoints through end of study, up to approximately 48 months.
Secondary Outcome Measure Information:
Title
Event-free survival (PFS)
Description
The Kaplan-Meier method will be used to assess EFS probabilities.
Time Frame
From the first day of treatment until any failure (resistant disease, relapse, or death), assessed up to 2 to 4 years.
Title
Overall survival (OS)
Description
The Kaplan-Meier method will be used to assess OS probabilities.
Time Frame
From the first day of treatment to time of death from any cause, assessed up 2 to 4 years.
Title
Incidence of adverse events (AEs)
Description
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.
Time Frame
Up to approximately 2 to 4 years.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suning Chen
Phone
+86-13814881746
Email
chensuning@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suning Chen
Organizational Affiliation
First Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suning Chen, PhD
Phone
+8613814881746
Email
chensuning@sina.com

12. IPD Sharing Statement

Learn more about this trial

Olverembatinib for FGFR1-rearranged Neoplasms

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