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An exploratory clinical study of Selinexor combined with zanubrutinib and Rituximab in the treatment of relapsed/refractory senile DLBCL

An exploratory clinical study of Selinexor combined with zanubrutinib and Rituximab in the treatment of relapsed/refractory senile DLBCL

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066961
Enrollment
Unknown
Registered
2022-12-22
Start date
2023-01-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Large B-cell Lymphoma

Interventions

Sigle arm:Selinexor+zanubrutinib+Rituximab

Sponsors

The Third People's Hospital of Fujian Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
70 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Know and sign the informed consent form; 2) Age = 70, male or female; 3) According to WHO classification standard in 2016, DLBCL confirmed by histopathology (including primary DLBCL or DLBCL transformed from inert lymphoma (such as follicular lymphoma)); 4) ECOG score: 0~2; 5) There must be at least one evaluable or measurable lesion meeting Lugano2014 standard. The longest diameter of lymph node lesions shall be>1.5 cm, and the longest diameter of extranodal lesions shall be>1 cm; 6) Sufficient organ and bone marrow functions, without serious hematopoietic dysfunction, heart, lung, liver and kidney dysfunction and immune deficiency; 7) The expected life span is more than 6 months; 8) The serum pregnancy test was negative, and effective contraceptive measures were taken within 6 months from the signing of the informed consent to the last chemotherapy

Exclusion criteria

Exclusion criteria: 1) Mixed lymphoma or gray area lymphoma; 2) Known central nervous system involvement; 3) Being involved in other clinical studies, or the time from the first drug administration to the end of the previous clinical study is less than 4 weeks; 4) Major surgery was performed within 28 days before starting the study treatment; 5) Active viral or bacterial infection that affects the subject's receiving the study treatment; 6) Patients with unstable or active cardiovascular diseases; a. Symptomatic myocardial ischemia b. Uncontrolled and clinically significant conduction abnormalities (e.g., patients with ventricular arrhythmia controlled by antiarrhythmic therapy are excluded; patients with 1-degree atrioventricular (AV) block or asymptomatic left anterior bundle branch block/right surgical branch block are not excluded) c. Congestive heart failure (CHF) grade defined by New York Heart Association (NYHA) = 3 d. Acute myocardial infarction (AMI) occurred within three months before the first administration 7) Allergies or contraindications to any drugs in the study protocol; 8) Zebutinib was used within 3 months before the previous exposure to celinidazole or C1D1; 9) Other situations that the researcher thinks are not suitable to participate in this clinical trial

Design outcomes

Primary

MeasureTime frame
Objective Response Rate;

Secondary

MeasureTime frame
Progression-free survival;Overall survival;

Countries

China

Contacts

Public ContactFu Haiying

The Third People's Hospital of Fujian Province

doctorfhy@163.com+86 13774560643

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026