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Trial Title:
Olverembatinib for FGFR1-rearranged Neoplasms
NCT ID:
NCT05521204
Condition:
Myeloproliferative Neoplasm
Acute Leukemia
Conditions: Official terms:
Neoplasms
Myeloproliferative Disorders
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Olverembatinib
Description:
Given PO
Arm group label:
Treatment Group
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.
Criteria for 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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215000
Country:
China
Status:
Recruiting
Contact:
Last name:
Suning Chen, PhD
Phone:
+8613814881746
Email:
chensuning@sina.com
Start date:
September 1, 2022
Completion date:
August 31, 2027
Lead sponsor:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05521204