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Trial Title:
Selinexor in Combination With R-CHOP as the First-line Therapy for TP53-mutated DLBCL Patients (Smart Trial)
NCT ID:
NCT06517511
Condition:
Diffuse Large B Cell Lymphoma
Conditions: Official terms:
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Conditions: Keywords:
TP53-mutated diffuse large B-cell lymphoma
Selinexor
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Selinexor Oral Tablet [Xpovio]
Description:
Selinexor (60mg po D1, 8) is added from the second cycle of R-CHOP regimen.
Arm group label:
Selinexor in combination with R-CHOP
Other name:
exportin 1 (XPO1) inhibitor
Intervention type:
Drug
Intervention name:
R-CHOP Protocol
Description:
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
Arm group label:
Selinexor in combination with R-CHOP
Other name:
R-CHOP regimen
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, doxorubicin, and prednisone) followed by selinexor maintenance for untreated
TP53-mutated diffuse large B-cell lymphoma (DLBCL) patients.
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 8 cycles of selinexor in combination with R-CHOP. After
8 cycles of induction therapy, if the response is assessed as complete remission (CR),
maintenance therapy with selinexor will be conducted.
The primary endpoint is complete response rate.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
1. Subjects fully understand and voluntarily participate in this study and sign
informed consent.
2. Aged ≥18, and ≤70 years, no gender limitation.
3. Patient was histologically confirmed diagnosis of diffuse large B-cell lymphoma
(DLBCL) and had TP53 mutations.
4. There must be at least one measurable or evaluable lesion that meets the evaluation
criteria for Lugano 2014 lymphoma.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2.
6. Expected survival ≥ 3 months.
7. Adequate function of bone marrow, liver, and kidney.
Key Exclusion Criteria:
1. DLBCL combined with other types of lymphoma. Transformed DLBCL.
2. DLBCL with central nervous system invasion.
3. The patients had previously received XPO1 inhibitors.
4. The patients have contraindications to any drug in the combined treatment.
5. 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.
6. Patients with the infection of human immunodeficiency virus (HIV) and/or acquired
Immunodeficiency syndrome.
7. Inability to swallow tablets, presence of malabsorption syndrome, or any other
gastrointestinal disease or dysfunction that may affect the absorption of the study
drug.
8. Pregnant and lactating women, and subjects of childbearing age who do not want to
use contraception.
9. Mentally ill persons or persons unable to obtain informed consent.
10. The investigators think that the patient is not suitable for the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun yat-sen university cancer center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Qingqing Cai, MD. PhD.
Phone:
0086-20-87342823
Email:
caiqq@sysucc.org.cn
Contact backup:
Last name:
Yi Xia, MD. PhD.
Phone:
0086-20-87342823
Email:
xiayi@sysucc.org.cn
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Rong Tao, MD.
Phone:
86-13651603660
Email:
taorong@xinhuamed.com.cn
Start date:
July 11, 2024
Completion date:
April 2028
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Fudan University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06517511
