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

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.

Study Overview

• Status: Recruiting
• Conditions: Double Hit Lymphoma; Triple Hit Lymphoma
• Intervention / Treatment: Drug: Selinexor+RCHOP

Detailed Description

This is a prospective, single-arm, single-center clinical study evaluating the first-line treatment of DH or TH lymphoma with Selinexor combined with RCHOP. There are three stages: screening, treatment and follow-up period. The screening period was 28 days before the first dose. Treatment period: Enrolled subjects were treated with Selinexor in combination with RCHOP every 21 days for a maximum of 6 cycles until the efficacy of SD or PD, drug toxicity became intolerable, subject withdrawal of consent, death, or continuation of chemotherapy deemed unsuitable by the investigator. Lugano2014 criteria were used to evaluate the efficacy during treatment. Objective effective rate, safety and survival data were observed during the experiment. After stopping treatment or completing 6 cycles of treatment, subjects entered the follow-up period, during which imaging evaluation (enhanced CT at focal site is recommended) was performed at the following intervals: once every 3 months for 2 years, once every 6 months for 3-5 years, and once every 5 years until the end of the follow-up period.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Cong Li; Phone Number: 15267115611; Email: licong@zjcc.org.cn

Study Locations

• China
  • Zhenjiang
    • Hangzhou, Zhenjiang, China, 310005
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: Cong Li, doctor; Phone Number: 15267115611; Email: licong@zjcc.org.cn
      • Contact: Haiyan Yang, doctor; Phone Number: 0571-88122192; Email: yanghy@zjcc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Selinexor+RCHOP; 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	Drug: Selinexor+RCHOP; XPO-1 inhibitor selinexor in combination with RCHOP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate	CR plus PR	From date of first day of treatment until the date of last day of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression Free Survival	From date of first day of treatmentuntil the date of first documented progression, assessed up to 24 months
OS	Overall Survival	From date of first day of treatmentuntil the date of first documented date of death from any cause, assessed up to 24 months
AE and SAE	Adverse event and serious adverse event	From date of first day of treatmentuntil 30 day after last treatment

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Investigators: Principal Investigator: Cong Li, Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 3, 2023

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Selinexor; RCHOP; Double/Triple Hit Lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: XRCHOP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No