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Trial Title:
Pro-miniCHOP-like Regimen for Treatment-naive Elderly Patients
NCT ID:
NCT05809180
Condition:
Diffuse Large B Cell Lymphoma
Conditions: Official terms:
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Rituximab
Pomalidomide
Conditions: Keywords:
Diffuse Large B-Cell Lymphoma
Orelabrutinib
pomalidomide
Rituximab
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Rituximab
Description:
Rituximab 375mg/m2 ivgtt d1;
Arm group label:
rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like
Other name:
MabThera
Intervention type:
Drug
Intervention name:
Orelabrutinib
Description:
Orelabrutinib 150mg per day oral administration till progresses or intolerant toxicity;
Arm group label:
rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like
Other name:
Yinuokai
Intervention type:
Drug
Intervention name:
Pomalidomide
Description:
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.
Arm group label:
rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like
Other name:
Anyve
Intervention type:
Drug
Intervention name:
Pro-miniCHOP-like regimen
Description:
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.
Arm group label:
rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like
Intervention type:
Drug
Intervention name:
R-miniCHOP-like regimen
Description:
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.
Arm group label:
rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
70 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
the First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215006
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhengming Jin
Phone:
+86 0512 67781856
Email:
jinzhengming519519@163.com
Contact backup:
Last name:
Nana Ping
Phone:
67781856
Email:
ping.chengcheng@163.com
Start date:
January 4, 2023
Completion date:
July 3, 2026
Lead sponsor:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05809180
