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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05498636
Other study ID # 202201
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date October 1, 2022
Est. completion date December 31, 2025

Study information

Verified date August 2022
Source The Affiliated Hospital of Qingdao University
Contact Hongwei Xue, doctor
Phone +8613475875599
Email hwx326@sina.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a phase II multi-center prospective clinical trail which investigates the efficacy and safety of Selinexor combined with prednisone, etoposide and lenalidomide in the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patient with high p53 and/or c-myc expression.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 67
Est. completion date December 31, 2025
Est. primary completion date July 30, 2025
Accepts healthy volunteers No
Gender All
Age group 16 Years to 80 Years
Eligibility Inclusion Criteria: 1. Any of the following as defined by the WHO, 2016 lymphoid neoplasm classifications and histologically confirmed:Diffuse large B-cell lymphoma with p53 and/ or c-Myc protein overexpression. Note: a. The cutoff value for p53 protein overexpression by immunohistochemistry (IHC) is 50%; cutoff value for c-Myc protein overexpression is 30-40%; b. For patients with high expression of C-Myc, dual-color FISH probes detection method should be used to check whether there is Myc and BCL2 gene rearrangement, which is cut by 5%; c. We need 5-10 pathological white films with a thickness of 5-10 um for review. 2. Patients who cannot tolerate or are unwilling to undergo intensive salvage therapy due to age or frailty; patients who have received at most three prior lines of regimen, in which stem cell transplantation is considered first-line. 3. With a life expectancy of = 3 months 4. Age = 18 years 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 6. At least 1 evaluable or measurable lesion that meets Lugano2014 criteria [Evaluable lesions: PET/CT examination showed increased uptake in lymph nodes or extranodal areas (higher than that in the liver), and pet/ct features were consistent with lymphoma. Measurable disease: Nodular lesions with longest diameter (LDi) greater than > 15mm or extranodal lesion with LDi >10mm. and FDG-PET positive lesions] 7. All screening laboratory tests should be performed according to the protocol and within 14 days before enrollment. Screening laboratory values must meet the following criteria: Routine blood tests (no blood transfusion, no G-CSF, no drug correction within 14 days before screening) : a. Hb=80g/L;b.ANC=1.0×109/L;c.PLT=75×109/L. Blood biochemistry: a.TBIL=1.5×upper limit of normal (ULN), or TBIL=3×ULN(if due to liver involvement); b. ALT and AST=3×ULN, or AST and ALT=5.0 x ULN(if due to liver involvement); c. Serum creatinine =1.5×ULN, or Estimated creatinine clearance = 50 mL/min (calculated using the formula of Cockcroft-Gault). Coagulation function (unless the subject is receiving anticoagulant treatment and the coagulation parameters (PT/INR and APTT) are within the expected range of anticoagulant treatment at the time of screening): INR=1.5×ULN; APTT=1.5×ULN. 8. Written informed consent of the patient Exclusion Criteria: 1. Patient with hemophagocytic syndrome 2. With uncontrolled serious active infections, including active tuberculosis 3. Known to have central nervous system (CNS), testicular, breast lymphoma; Patients with massive pleural and peritoneal effusion 4. Previous treatment with Selinexor or lenalidomide in the past 6 months 5. Previous treatment with allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation. 6. Autologous hematopoietic stem cell transplantation was performed within 6 months prior to initiation of treatment. 7. Major surgery <28 days of C1D1. 8. Live vaccine (excluding attenuated influenza vaccine) within 28 days before study treatment. 9. Ongoing participation in another clinical study, or planned initiation of treatment in this study less than 4 weeks from the end of treatment in the previous clinical study. 10. Patients with serious medical diseases, such as organic heart disease, resulting in clinical symptoms or cardiac dysfunction (=NYHA grade 2), a history of myocardial infarction within 6 months prior to screening, echocardiographic ejection fraction < 50%, and severe thromboembolic diseases. 11. Positive HIV serologies before inclusion. 12. Other malignant tumors in the past 5 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, and gastrointestinal intramucosal carcinoma after radical treatment. 13. Additional systemic antitumor therapy may be accepted during the study period. 14. Other conditions that patients considered unsuitable for inclusion by the researchers.

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
Selinexor combined with Prednisone, Etoposide, and Lenalidomide
Selinexor combined with Prednisone, Etoposide, and Lenalidomide

Locations

Country Name City State
China the affiliated hospital of Qingdao University Qingdao Shandong

Sponsors (1)

Lead Sponsor Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary CR rate complete remission rate after 4 cycles of SPEL regimen At the end of Cycle 4 (each cycle is 28 days)
Primary ORR overall response rate after 4 cycles of SPEL regimen At the end of Cycle 4 (each cycle is 28 days)
Secondary AE adverse event of SPEL regimen from the first dose of SPEL regimen to 3 months after last dose of the regimen
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