Actively Recruiting
Selinexor Plus R-CHOP in High-risk GCB-subtype Diffuse Large B-Cell Lymphoma
Led by Li Zhiming · Updated on 2024-06-17
50
Participants Needed
6
Research Sites
179 weeks
Total Duration
On this page
Sponsors
L
Li Zhiming
Lead Sponsor
A
Antengene Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 35 patients plan to be enrolled in about 6-8 study sites of the study. And the objective is to Evaluate the safety and efficacy of XR-CHOP in High-Risk (IPI 3-5) GCB-subtype DLBCL.The enrollment period for this study is expected to be approximately 18 months. The study will end when all patients have completed 6 cycles treatment/follow-up since the initiation of the study drug, or the last patient has expired, has been lost to follow-up, or has withdrawn consent, whichever occurs first.
CONDITIONS
Official Title
Selinexor Plus R-CHOP in High-risk GCB-subtype Diffuse Large B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent
- Age between 18 and 75 years
- Histologically confirmed high-risk germinal center B-cell subtype diffuse large B-cell lymphoma
- No prior chemotherapy or radiotherapy for this lymphoma except up to 5 days of glucocorticoids for symptom control
- International Prognostic Index (IPI) score between 3 and 5
- Measurable disease on CT or PET scan with at least one lymph node >1.5 cm or one extranodal lesion >1 cm
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate bone marrow function with ANC ≥1.5 x10^9/L, platelets ≥100 x10^9/L (or ≥75 x10^9/L if bone marrow involvement), and hemoglobin ≥85 g/L
- Adequate liver and kidney function with AST/ALT ≤2x upper limit of normal (ULN) or ≤5x ULN if due to lymphoma, total bilirubin ≤2x ULN or ≤5x ULN if Gilbert syndrome or lymphoma involvement, and creatinine clearance ≥30 mL/min
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study
- Men must agree to avoid sperm donation during the study and for 14 months after last dose
You will not qualify if you...
- Diagnosis of other lymphoma types such as MALT lymphoma, composite lymphoma, Gray zone lymphoma, Richter Syndrome, primary mediastinal large B-cell lymphoma, or T-cell rich large B-cell lymphoma
- Active central nervous system lymphoma or meningeal involvement, except treated CNS disease in remission
- Testicular lymphoma involvement or more than two extranodal disease sites
- Previous treatment with Selinexor or other XPO1 inhibitors
- Contraindications to any study drugs
- Major surgery within 14 days before treatment start (except for diagnosis procedures)
- Life-threatening illness or medical condition that could affect safety or study compliance
- Clinically unstable infection requiring intravenous antibiotics, antivirals, or antifungals within 7 days before treatment
- Active hepatitis B, hepatitis C, or HIV infection except controlled cases as specified
- Pregnant or breastfeeding women
- Underweight participants judged by the investigator to be at risk from weight changes
- Life expectancy less than 6 months
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Department of Medical Oncology, Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
Not Yet Recruiting
3
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Not Yet Recruiting
4
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
Not Yet Recruiting
5
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Not Yet Recruiting
6
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, China, 315000
Not Yet Recruiting
Research Team
Z
Zhiming Li, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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