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Pro-miniCHOP-like Regimen for Treatment-naive Elderly Patients | Clinical Trials | Clareo Health

RECRUITINGNA

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

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

NCT05809180•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.

Detailed Description

The study will start with an initial 21-days of induction therapy with combination of orelabrutinib, pomalidomide and rituximab(Pro regimen) in eligible patients, following contrast computed temography(CT) to guide the next treatment. Patients whose lesions have 25% or more reduction will next receive Pro-miniCHOP-like regimen for 6 cycles. Patients with reduction less than 25% will receive R-miniCHOP-like regimen also for 6 cycles. After that, maintenance therapy with pomalidomide for two years will be given to patients undergoing Pro-miniCHOP-like regimen.

Eligibility

Age

70 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histopathologically or Cytologically confirmed newly diagnosed untreated DLBCL;
•2. There is at least one radiographically measurable lesion (i.e., ≥ 15mm in diameter);
•3. Age ≥ 70 years;
•4. Life expectancy \>3 months;
•5. Patients with proper organic function (alanine aminotransferase, bilirubin, creatinine \< 3 times the upper limit of normal; cardiac ejection fraction ≥ 50%; SPO2\>90% under non-oxygenated conditions).
•6. Written informed consent obtained from the subject.

Exclusion Criteria

•1. Patients with severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine \> 3 times the upper limit of normal);
•2. Patients with organic heart disease with clinical symptoms or cardiac dysfunction (NYHA grade ≥2);
•3. Uncontrolled active infection;
•4. Patients with central nervous system DLBCL;
•5. A history of vascular embolism;
•6. Co-existence of other tumors;
•7. Systemic corticosteroid therapy is needed;
•8. Any other psychological conditions that prevent patients from participating in the study or signing the informed consent form.

Locations (1)

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Key Dates

Start Date

January 4, 2023

Primary Completion Date

July 3, 2025

Completion Date

July 3, 2026

Last Updated

April 20, 2023

Enrollment

ESTIMATED participants

Conditions

Diffuse Large B Cell Lymphoma

Interventions

Rituximab

DRUG

Orelabrutinib

DRUG

Pomalidomide

DRUG

Pro-miniCHOP-like regimen

DRUG

R-miniCHOP-like regimen

DRUG

Contacts

Zhengming Jin

CONTACT

67781856 jinzhengming519519@163.com

Changju Qu

CONTACT

67781856 qcj310@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 20, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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