Status:
RECRUITING
Selinexor Plus R-CHOP in High-risk GCB-subtype Diffuse Large B-Cell Lymphoma
Lead Sponsor:
Li Zhiming
Collaborating Sponsors:
Antengene Corporation
Conditions:
DLBCL Germinal Center B-Cell Type
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a phase II, multicenter, single-arm and open-label study to explore Selinexor in combination with standard of care R-CHOP in New Diagnosed high-risk GCB-subtype DLBCL (IPI 3-5). Approximately ...
Detailed Description
This is a phase II, multicenter, single-arm and open-label study to explore Selinexor in combination with standard of care R-CHOP in New Diagnosed high-risk GCB-subtype DLBCL (IPI 3-5). Approximately ...
Eligibility Criteria
Inclusion
- Patients must meet all of the following inclusion criteria to be eligible to enroll in this study:
- Willing and able to written informed consent (ICF) .
- Age ≥ 18 years and ≤ 75 years.
- Histologically confirmed Diffuse Large B-Cell Lymphoma of the germinal center B-cell(DLBCL) subtype by Hans.
- Patients no prior chemotherapy or radiotherapy for DLBCL, with the exception of no more than 5 days of treatment with glucocorticoids for symptom control.
- International Prognostic Index score of 3-5.
- Computed Tomography(CT)/Positron emission tomography (PET) positive measurable disease per the Lugano Classification 2014, having at least 1 node with longest diameter (LDi) greater than \> 1.5cm or 1 extranodal lesion with LDi \>1 cm.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- Adequate bone marrow function at Screening(Except for underlying diseases, such as secondary hypersplenism due to bone marrow invasion or splenic invasion identified by the investigator).
- Absolute neutrophil count (ANC)≥1.5×109/L;
- Platelet count (PLT) ≥100×109/L(no platelet transfusion within 14 days prior to C1D1), or PLT≥ 75×109/L if due to lymphoma with bone marrow involvement.
- Hemoglobin (HB)≥85g/L(no red blood cell transfusion within 14 days prior to C1D1).
- Adequate hepatic and renal function:
- Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) ≤2.0 x upper limit of normal (ULN), or AST and ALT≤5.0 x ULN(if due to lymphoma involvement),
- Serum total bilirubin ≤2×ULN, or Serum total bilirubin ≤5×ULN if due to Gilbert syndrome or lymphoma involvement.
- Estimated creatinine clearance ≥ 30 mL/min (calculated using the formula of Cockroft-Gault).
- Participants of childearing potential must agree to use highly effective methods of contraception during the duration of the study and following the last dose of study treatment, female and male participants should continue contraception for 14 and 11 months, respectively.
- Female participants of childbearing potential must have a negative serum pregnancy test at screening(Non-Childbearing potential: Age \>50 years and naturally amenorrhoeic for \>1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy).
- Male participants must agree to avoid sperm donation during the duration of the study and 14 months following the last dose of study treatment.
Exclusion
- Inclusion/
Key Trial Info
Start Date :
July 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05422066
Start Date
July 26 2022
End Date
December 31 2025
Last Update
June 17 2024
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Medical Oncology, Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
2
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
3
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
4
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079