Status:
UNKNOWN
XPO-1 in Combination With RCHOP for DH/TH Lymphoma
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Double Hit Lymphoma
Triple Hit Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study was to evaluate the efficacy and safety of Selinexor in combination with RCHOP in first-line treatment of patients with DH or TH lymphoma.
Detailed Description
This is a prospective, single-arm, single-center clinical study evaluating the first-line treatment of DH or TH lymphoma with Selinexor combined with RCHOP. There are three stages: screening, treatmen...
Eligibility Criteria
Inclusion
- Volunteer to participate in clinical studies
- Age: 18\~75 (inclusive), male and female.
- Histopathologically confirmed high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 gene rearrangement.
- No previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor therapy.
- ECOG score is 0-2.
- there must be at least one evaluable or measurable lesion that meets Lugano2014 criteria.
- Adequate organ and bone marrow function.
- Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination.
- Serum pregnancy test negative
Exclusion
- Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination. 1) Mixed lymphoma (Hodgkin's lymphoma + non-Hodgkin's lymphoma), or DLBCL transformed from inert non-Hodgkin's lymphoma, or gray zone lymphoma (lymphoma between DLBCL and Hodgkin's lymphoma), or inert lymphoma with MYC, BCL2, BCL6 gene rearrangement.
- known central nervous system involvement.
- received prior anti-tumor therapy
- Is participating in another clinical study or is receiving the first investigational drug less than 4 weeks after the completion of treatment in the previous clinical study
- Had other malignant tumors in the past 5 years
- Major surgery was performed within 28 days prior to study initiation
- Cardiovascular function is unstable
- Active infection
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05974085
Start Date
August 1 2022
End Date
March 1 2024
Last Update
August 3 2023
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhenjiang, China, 310005