A Single-arm, Multi-center, Phase Ib/II Study of Selinexor in Combination With R-CHOP Followed by Selinexor Maintenance for Untreated EBV-positive DLBCL Patients (Xplore Trial)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This is a prospective, single-arm, multi-center, phase Ib/II clinical trial to evaluate the safety, tolerability, and efficacy of selinexor in combination with R-CHOP (rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone) followed by selinexor maintenance for untreated EBV-positive diffuse large B-cell lymphoma (DLBCL) patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• Subjects fully understand and voluntarily participate in this study and sign informed consent

• Age ≥18, ≤70 years, no gender limitation.

• Histologically confirmed diagnosis of EBV-positive diffuse large B-cell lymphoma (DLBCL) (more than 50% of tumor cells are positive with EBV encoded small RNAs (EBERs) in situ hybridization were considered EBERs positive).

• Untreated patients, except for the short-time use of prednisone for controlling tumor-induced symptoms (no more than 30mg/d (or other equivalent amounts of other glucocorticoids), no more than 7 days).

• There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma: measurable lesion: Positron emission tomography/computed tomography (PET/CT) or CT and/or MRI, intranodal lesions with long diameter \>1.5cm, and short diameter \>1.0cm, or extranodal lesions with long diameter \> 1.0 cm.

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2.

• Expected survival ≥ 3 months.

• Adequate function of bone marrow:

• White blood cell ≥3.0×10E9/L, absolute neutrophil count ≥1.5×10E9/L Platelet ≥100×10E9/L (Bone marrow invasive patient≥75×109/L) Hemoglobin≥ 90g/L No granulocyte growth factor, platelet, or red blood cell transfusions were received within 14 days prior to examination.

• Adequate function of the liver and renal:

• Total bilirubin≤2×upper limit of normal (ULN) (patients with liver invasion or Gilbert syndrome ≤5×ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (patients with liver invasion ≤5×ULN) Serum creatinine ≤1.5×ULN or creatinine clearance rate ≥60 mL/min

⁃ The patients agree to take effective contraceptive measures during the study period and till 12 months after the last administration of the study treatment.

Locations
Other Locations
China
Sun Yat-sen Universitiy Cancer Center
RECRUITING
Guangzhou
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Qingqing Cai, MD. PhD.
caiqq@sysucc.org.cn
0086-20-87342823
Backup
Huiqiang Huang, MD. PhD.
huanghq@sysucc.org.cn
0086-20-87342823
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 54
Treatments
Experimental: Selinexor in Combination With R-CHOP
Patients with untreated EBV-positive diffuse large B-cell lymphoma will receive sequentially higher doses of selinexor in combination with R-CHOP regimen from the second cycle of R-CHOP (3 weeks per cycle).The initial dose of selinexor is 40mg qw po.~After 8 cycles of induction therapy, if the response is assessed as complete remission (CR), maintenance therapy with selinexor will be conducted.
Sponsors
Collaborators: Antengene Corporation, Fudan University
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov

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