XPO-1 in Combination With RCHOP for DH/TH Lymphoma

NCT ID: NCT05974085

Last Updated: 2023-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2024-03-01

Brief Summary

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.

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.

Conditions

Double Hit Lymphoma; Triple Hit Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Selinexor+RCHOP

Intervention Type: DRUG

XPO-1 inhibitor selinexor in combination with RCHOP

Interventions

Selinexor+RCHOP

XPO-1 inhibitor selinexor in combination with RCHOP

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yang haiyan

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cong Li

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhenjiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Cong Li

Role: CONTACT

licong@zjcc.org.cn

15267115611

Facility Contacts

Cong Li, doctor

Role: primary

licong@zjcc.org.cn

15267115611

Haiyan Yang, doctor

Role: backup

yanghy@zjcc.org.cn

0571-88122192

Other Identifiers

XRCHOP

Identifier Type: -

Identifier Source: org_study_id