RecruitingNot ApplicableNCT05809180

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

Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

35 participants

Start Date

Jan 4, 2023

Study Type

INTERVENTIONAL

Conditions

Diffuse Large B Cell Lymphoma

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.

Eligibility

Min Age: 70 Years

Inclusion Criteria6

Histopathologically or Cytologically confirmed newly diagnosed untreated DLBCL;
There is at least one radiographically measurable lesion (i.e., ≥ 15mm in diameter);
Age ≥ 70 years;
Life expectancy \>3 months;
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).
Written informed consent obtained from the subject.

Exclusion Criteria8

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

Interventions

DRUGRituximab

Rituximab 375mg/m2 ivgtt d1;

DRUGOrelabrutinib

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

DRUGPomalidomide

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.

DRUGPro-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.

DRUGR-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.