Status:
RECRUITING
Selinexor in Combination With R-CHOP as the First-line Therapy for TP53-mutated DLBCL Patients (Smart Trial)
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Fudan University
Conditions:
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is a prospective, single-arm, multi-center, phase II clinical trial to evaluate the efficacy and safety of selinexor in combination with R-CHOP (rituximab, cyclophosphamide, vincristine, doxorubi...
Detailed Description
The purpose of this phase II clinical trial is to evaluate the efficacy and safety of selinexor in combination with R-CHOP for untreated TP53-mutated DLBCL patients. The induction phase consisted of ...
Eligibility Criteria
Inclusion
- Key
- Subjects fully understand and voluntarily participate in this study and sign informed consent.
- Aged ≥18, and ≤70 years, no gender limitation.
- Patient was histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) and had TP53 mutations.
- There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2.
- Expected survival ≥ 3 months.
- Adequate function of bone marrow, liver, and kidney.
- Key
Exclusion
- DLBCL combined with other types of lymphoma. Transformed DLBCL.
- DLBCL with central nervous system invasion.
- The patients had previously received XPO1 inhibitors.
- The patients have contraindications to any drug in the combined treatment.
- Patients with chronic active hepatitis B or active hepatitis C. If the background hepatitis B Surface Antigen (HBsAg) and/or hepatitis B core Antibody (HBcAb) or hepatitis C Virus (HCV) antibody are positive, the further determination for Hepatitis B Virus (HBV) DNA (no more than 2500 copies /mL or 500 IU/mL) and HCV RNA (no more than the lower limit of the assay) can be included. The patients with HBsAg and/or HBcAb positive need to receive anti-HBV drugs.
- Patients with the infection of human immunodeficiency virus (HIV) and/or acquired Immunodeficiency syndrome.
- Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug.
- Pregnant and lactating women, and subjects of childbearing age who do not want to use contraception.
- Mentally ill persons or persons unable to obtain informed consent.
- The investigators think that the patient is not suitable for the study.
Key Trial Info
Start Date :
July 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06517511
Start Date
July 11 2024
End Date
April 1 2028
Last Update
July 24 2024
Active Locations (2)
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1
Sun yat-sen university cancer center
Guangzhou, Guangdong, China, 510060
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032