NCT05974085

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Selinexor+RCHOP	XPO-1 inhibitor selinexor in combination with RCHOP

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-12-31
• Completion: 2024-03-01
• First posted: 2023-08-03
• Last updated: 2023-08-03

Locations

1 site across 1 country: China