Clinical trial · Interventional
Selinexor Combined With R-GemOx as Second-line Treatment in Patients With Diffuse Large B-cell Lymphoma
Selinexor Combined With R-GemOx as Second-line Treatment in Patients With Diffuse Large B-cell Lymphoma: a Single-arm, Single-centre, Open-label Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this interventional study is to evaluate efficiency and safety in prior one-line treated diffuse large B-cell lymphoma. The main questions it aims to answer are: * Complete remission rate * Objective remission rate * Progression-free survival * tolerance Participants will recevied a minimum of 2 and a maximum of 6 cycles of R-GemOx(rituximab 375 mg/m2 IV on day 1 , Gemcitabine 1000 mg/m2, Oxaliplatin 100 mg/m2 IV on day 2) and 60 mg selinexor on days 1, 8, and 15 of each cycle
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma, Not Otherwise Specified | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| selinexor | Drug | Selinexor | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Patients will receive selinexor PO on days 1, 8, and 15 of a 21 week cycle. R-GemOx will be given at standard dosing every 21 days
- interventionNames
- Drug: selinexor
Primary outcomes (1)
- measure
- Complete remission rate
- timeFrame
- UP to 2 years
- description
- Response rates will be estimated as proportions with 95% Wilson confidence intervals
Secondary outcomes (2)
- measure
- Progression-free survival
- timeFrame
- From baseline to disease progression or death from any cause, assessed up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Have pathologically confirmed CD20 positive de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma) * HIV-seropositive * Age 18-75 years * ECOG PS≤2 * Positron emission tomography (PET) positive measurable disease with at least one node having the longest diameter (LDi)\>1.5cm or one extranodal lesion with LDi\>1cm (per the Lugano Criteria 2014) (Documentation to be provided) * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 × Upper limit of normal value (ULN), or ≤ 5 in the presence of known lymphoma involving the liver × ULN; Total serum bilirubin ≤ 2 × ULN, or ≤ 5 when Gilbert syndrome or known lymphoma affects the liver × ULN; Creatinine clearance (CrCl) calculated according to Cockcroft Gault formula ≥ 30 mL/min; * Absolute neutrophil count (ANC)≥1.5×10\^9/L,or Platelet count≥75×10\^9/L(No platelet were transfused within 14 days before the treatment of the study drug),or Hemoglobin≥80g/L(No red blood cells were transfused within 14 days before the treatment of the study drug) * Written informed consent in accordance with federal, local, and institutional guidelines * Patients understanding the characteristics of the disease and voluntarily joins the study program for treatment and follow-up * No other serious diseases in conflict with this program * Investigator believe that subjects can benefit Exclusion Criteria: * Patients with known central nervous system involvement by lymphoma; * Patients with a history of autoimmune diseases or syndrome requiring systemic use of steroid, such as hypophysitis, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism and hypothyroidism * Patients received systemic glucocorticoid (prednisone \>20mg/d) or any other immunosuppressive therapy within 7 days before the first administration,excluding nasal spray inhalation or other topical glucocorticoids; * Uncontrolled heart diseases, including unstable angina pectoris, acute myocardial infarction 6 months before randomization, congestive heart failure (NYHA), cardiac function grade greater than grade III or IV, or left ventricular ejection fraction\<50%; * Patients previously treated with selinexor; * History of severe allergic reactions (as determined by treating physician) attributed to the drugs being used in the study; * Patients undergoing organ transplantation; * Diagnosed as malignant tumor other than lymphoma or receiving treatment,excluding: 1. Malignant tumors that have received treatment for the purpose of cure and have not developed known active diseases for ≥ 5 years before enrollment 2. Basal cell carcinoma of the skin (excluding melanoma) with adequate treatment and no signs of disease 3. Cervical carcinoma in situ with adequate treatment and no signs of disease * Patients with grade 2 or more neurotoxicity occurred within two weeks before treatment; * Severe infection; * Drug abuse, medical psychological or social conditions that may interfere with the subject's participation in the study or the evaluation of the results of the study; * Any active, serious psychiatric, medical, or other conditions/situations which, in the treating physician's opinion, could compromise the patient's safety
References
Publications (17)
- RESULTKrok-Schoen JL, Fisher JL, Stephens JA, Mims A, Ayyappan S, Woyach JA, Rosko AE. Incidence and survival of hematological cancers among adults ages >/=75 years. Cancer Med. 2018 Jul;7(7):3425-3433. doi: 10.1002/cam4.1461. Epub 2018 Apr 13. PMID 29654631
- RESULTHarris LJ, Patel K, Martin M. Novel Therapies for Relapsed or Refractory Diffuse Large B-Cell Lymphoma. Int J Mol Sci. 2020 Nov 13;21(22):8553. doi: 10.3390/ijms21228553. PMID 33202794
- RESULTCrump M, Neelapu SS, Farooq U, et al. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017;130(16):1800-1808. Blood. 2018 Feb 1;131(5):587-588. doi: 10.1182/blood-2017-11-817775. No abstract available. PMID 29437609
- RESULTPfreundschuh M, Trumper L, Osterborg A, Pettengell R, Trneny M, Imrie K, Ma D, Gill D, Walewski J, Zinzani PL, Stahel R, Kvaloy S, Shpilberg O, Jaeger U, Hansen M, Lehtinen T, Lopez-Guillermo A, Corrado C, Scheliga A, Milpied N, Mendila M, Rashford M, Kuhnt E, Loeffler M; MabThera International Trial Group. CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: a randomised controlled trial by the MabThera International Trial (MInT) Group. Lancet Oncol. 2006 May;7(5):379-91. doi: 10.1016/S1470-2045(06)70664-7. PMID 16648042
- RESULTCunningham D, Hawkes EA, Jack A, Qian W, Smith P, Mouncey P, Pocock C, Ardeshna KM, Radford JA, McMillan A, Davies J, Turner D, Kruger A, Johnson P, Gambell J, Linch D. Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone in patients with newly diagnosed diffuse large B-cell non-Hodgkin lymphoma: a phase 3 comparison of dose intensification with 14-day versus 21-day cycles. Lancet. 2013 May 25;381(9880):1817-26. doi: 10.1016/S0140-6736(13)60313-X. Epub 2013 Apr 22. PMID 23615461
- RESULTArboe B, Olsen MH, Gorlov JS, Duun-Henriksen AK, Dalton SO, Johansen C, de Nully Brown P. Treatment intensity and survival in patients with relapsed or refractory diffuse large B-cell lymphoma in Denmark: a real-life population-based study. Clin Epidemiol. 2019 Mar 4;11:207-216. doi: 10.2147/CLEP.S178003. eCollection 2019.