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RECRUITING
NCT05809180
NA

Pro-miniCHOP-like Regimen for Treatment-naive Elderly Patients

Sponsor: The First Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

Summary

The proposed study is a prospective, single-center and open-ended study in patients over the age of 70 with treatment-naive diffuse large B-cell lymphoma (DLBCL). This study intends to explore a new treatment pattern using Pro-miniCHOP-like regimen and simultaneously evaluate its safety and efficacy for future clinical practice.

Official title: Prospective Exploratory Clinical Study of Orelabrutinib, Pomalidomide, Rituximab Combined With miniCHOP-like Regimen in Treatment-naive Elderly Patients With DLBCL

Key Details

Gender

All

Age Range

70 Years - Any

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2023-01-04

Completion Date

2026-07-03

Last Updated

2023-04-20

Healthy Volunteers

No

Interventions

DRUG

Rituximab

Rituximab 375mg/m2 ivgtt d1;

DRUG

Orelabrutinib

Orelabrutinib 150mg per day oral administration till progresses or intolerant toxicity;

DRUG

Pomalidomide

Pomalidomide 4mg d1-7 each cycle. After Phase II of treatment, single agent pomalidomide 4 mg d1-d7 in 21-day cycles for 2 years.

DRUG

Pro-miniCHOP-like regimen

rituximab 375mg/m2 ivgtt d1; orelabrutinib 150mg per day oral administration till progresses or intolerant toxicity; pomalidomide 4mg d1-7; cyclophosphamide 400mg/m2 ivgtt d2; doxorubicin 25mg/m2 ivgtt d2/ doxorubicin liposome 15 mg/m2 ivgtt d2; vindesine 2mg ivgtt d2; dexamethasone 10mg ivgtt d2-6.

DRUG

R-miniCHOP-like regimen

rituximab 375mg/m2 ivgtt d1; cyclophosphamide 400mg/m2 ivgtt d2; doxorubicin 25mg/m2 ivgtt d2/ doxorubicin liposome 15 mg/m2 ivgtt d2; vindesine 2mg ivgtt d2; dexamethasone 10mg ivgtt d2-6.

Locations (1)

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China