Selinexor Plus R-CHOP in High-risk GCB-subtype Diffuse Large B-Cell Lymphoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLi Zhiming

About this trial

This is a phase II, multicenter, single-arm and open-label study to explore Selinexor in combination with standard of care R-CHOP in New Diagnosed high-risk GCB-subtype DLBCL (IPI 3-5). Approximately 35 patients plan to be enrolled in about 6-8 study sites of the study. And the objective is to Evaluate the safety and efficacy of XR-CHOP in High-Risk (IPI 3-5) GCB-subtype DLBCL.The enrollment period for this study is expected to be approximately 18 months. The study will end when all patients have completed 6 cycles treatment/follow-up since the initiation of the study drug, or the last patient has expired, has been lost to follow-up, or has withdrawn consent, whichever occurs first.

Eligibility criteria

Qualifiers

Willing and able to written informed consent (ICF) .

Age ≥ 18 years and ≤ 75 years.

Histologically confirmed Diffuse Large B-Cell Lymphoma of the germinal center B-cell(DLBCL) subtype by Hans.

Patients no prior chemotherapy or radiotherapy for DLBCL, with the exception of no more than 5 days of treatment with glucocorticoids for symptom control.

Disqualifiers

Willing and able to written informed consent (ICF) .

Age ≥ 18 years and ≤ 75 years.

Histologically confirmed Diffuse Large B-Cell Lymphoma of the germinal center B-cell(DLBCL) subtype by Hans.

Patients no prior chemotherapy or radiotherapy for DLBCL, with the exception of no more than 5 days of treatment with glucocorticoids for symptom control.

Trial design

Treatments tested in this trial

  • Selinexor
  • Rituximab
  • Cyclophosphamide
  • Doxorubicin
  • Vincristine
  • Prednisone

Treatment groups

50 Participants
are divided into 1 treatment group

Locations

6
Department of Medical Oncology, Sun Yat-Sen University Cancer Center510060, GuangzhouGuangdong, China
Henan Cancer Hospital450008, ZhengzhouHenan, China
Hubei Cancer Hospital430079, WuhanHubei, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology430022, WuhanHubei, China

Sponsors and collaborators

Li Zhiming

Lead sponsor

Sun Yat-sen University

Sponsor institution

Antengene Corporation

Collaborator