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

NCT05974085 | Unknown Phase 2

• 1 other identifier: XRCHOP
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Double Hit Lymphoma; Triple Hit Lymphoma

Keywords

Double/Triple Hit Lymphoma; Selinexor; RCHOP

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  CR plus PR

  From date of first day of treatment until the date of last day of treatment

Secondary Outcomes (3)

• PFS

  From date of first day of treatmentuntil the date of first documented progression, assessed up to 24 months

• OS

  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

  From date of first day of treatmentuntil 30 day after last treatment

Study Arms (1)

Selinexor+RCHOP

EXPERIMENTAL

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

Interventions

Selinexor+RCHOP DRUG

XPO-1 inhibitor selinexor in combination with RCHOP

Selinexor+RCHOP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteer to participate in clinical studies
• Age: 18\~75 (inclusive), male and female.
• Histopathologically confirmed high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 gene rearrangement.
• No previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor therapy.
• ECOG score is 0-2.
• there must be at least one evaluable or measurable lesion that meets Lugano2014 criteria.
• Adequate organ and bone marrow function.
• Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination.
• Serum pregnancy test negative

You may not qualify if:

• 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.
• known central nervous system involvement.
• received prior anti-tumor therapy
• 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
• Had other malignant tumors in the past 5 years
• Major surgery was performed within 28 days prior to study initiation
• Cardiovascular function is unstable
• Active infection

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhenjiang, 310005, China

RECRUITING

Study Officials

• Cong Li

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cong Li

CONTACT

15267115611; licong@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: August 3, 2023
• Study Start: August 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: March 1, 2024
• Last Updated: August 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)