Clinical trial · Interventional
XPO-1 in Combination With RCHOP for DH/TH Lymphoma
Prospective, Single-arm, Single-center, Phase II Clinical Study of XPO-1 Inhibitor Selinexor in Combination With RCHOP Regimen in the Treatment of Double Hit/Triple Hit B Cell Lymphoma
NCT05974085CI-TRIAL-00068484unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study was to evaluate the efficacy and safety of Selinexor in combination with RCHOP in first-line treatment of patients with DH or TH lymphoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Double Hit Lymphoma | High Grade B-Cell Lymphoma with MYC and BCL2 or BCL6 Rearrangements | ALIAS | 0.90 |
| Triple Hit Lymphoma | High Grade B-Cell Lymphoma with MYC, BCL2, and BCL6 Rearrangements | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Selinexor+RCHOP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Selinexor+RCHOP
- description
- Selinexor: 60 mg QW Rituximab: 375 mg/m2, d0 Vincristine: 4 mg, d1 Epirubicin: 75 mg/m2, d1 or Liposomal doxorubicin: 35 mg/m2, d1 Cyclophosphamide: 750 mg/m2, d1 Prednisone: 100 mg, d1-5
- interventionNames
- Drug: Selinexor+RCHOP
Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- From date of first day of treatment until the date of last day of treatment
- description
- CR plus PR
Secondary outcomes (3)
- measure
- PFS
- timeFrame
- From date of first day of treatmentuntil the date of first documented progression, assessed up to 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Volunteer to participate in clinical studies 2. Age: 18\~75 (inclusive), male and female. 3. Histopathologically confirmed high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 gene rearrangement. 4. No previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor therapy. 5. ECOG score is 0-2. 6. there must be at least one evaluable or measurable lesion that meets Lugano2014 criteria. 7. Adequate organ and bone marrow function. 8. Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination. 9. Serum pregnancy test negative Exclusion Criteria: 1. Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination. 1) Mixed lymphoma (Hodgkin's lymphoma + non-Hodgkin's lymphoma), or DLBCL transformed from inert non-Hodgkin's lymphoma, or gray zone lymphoma (lymphoma between DLBCL and Hodgkin's lymphoma), or inert lymphoma with MYC, BCL2, BCL6 gene rearrangement. 2. known central nervous system involvement. 3. received prior anti-tumor therapy 4. Is participating in another clinical study or is receiving the first investigational drug less than 4 weeks after the completion of treatment in the previous clinical study 5. Had other malignant tumors in the past 5 years 6. Major surgery was performed within 28 days prior to study initiation 7. Cardiovascular function is unstable 8. Active infection
References
Publications (1)
- DERIVEDLi C, Chen X, Xu J, Lei T, Yu H, Peng S, Han S, Yang H. Selinexor Combined With R-CHOP Achieved a High Response Rate in Newly Diagnosed Double/Triple Hit Lymphoma. Blood Adv. 2026 Jul 21:bloodadvances.2025018580. doi: 10.1182/bloodadvances.2025018580. Online ahead of print. PMID 42480213