Back to resultsPro-miniCHOP-like Regimen for Treatment-naive Elderly Patients
Primary Purpose
Diffuse Large B Cell Lymphoma
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Rituximab
Orelabrutinib
Pomalidomide
Pro-miniCHOP-like regimen
R-miniCHOP-like regimen
Sponsored by
About this trial
This is an interventional treatment trial for Diffuse Large B Cell Lymphoma focused on measuring Diffuse Large B-Cell Lymphoma, Orelabrutinib, pomalidomide, Rituximab
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- the First Affiliated Hospital of Soochow UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like
Arm Description
Phase I(induction therapy): Patients receive Rituximab on day 1, Pomalidomide on days 1-7 and oral administration of Orelabrutinib per day. Phase II(stratified response therapy): Part A: (25% or more reduction): Patients receive Pro-miniCHOP-like regimen every 21 days for 6 cycles.(Rituximab on day 1, Pomalidomide on days 1-7, Orelabrutinib per day till progression or intolerant toxicity, Cyclophosphamide on day 2, Doxorubicin/Doxorubicin Liposome on day 2, Vindesine on day 2 and Dexamethasone on days 2-6). Part B: (reduction less than 25%): Patients receive R-miniCHOP-like regimen every 21 days for 6 cycles.(Rituximab on day 1, Cyclophosphamide on day 2, Doxorubicin/Doxorubicin Liposome on day 2, Vindesine on day 2 and Dexamethasone on days 2-6). Phase III(maintenance and follow-up): Patients take Pomalidomide orally on days 1-7 in a cycle of 21 days for 2 years.
Outcomes
Primary Outcome Measures
Overall Response Rate(ORR) after Pro-miniCHOP-like regimen
The rate of patients who achieved complete response and partial response after Pro-miniCHOP-like regimen.
Complete Response Rate(CRR) after Pro-miniCHOP-like regimen
The rate of patients who achieved complete response after Pro-miniCHOP-like regimen.
Secondary Outcome Measures
Incidence of treatment-emergent adverse events, treatment-related adverse events and serious adverse events
The safety and tolerability of the therapeutic regimen measured by the incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events.
Overall Response Rate(ORR) after Pro induction regimen
The rate of patients who achieved complete response and partial response after Pro induction regimen.
Complete Response Rate(CRR) after Pro induction regimen
The rate of patients who achieved complete response after Pro induction regimen.
Overall Survival (OS)
OS will be assessed from the first drug given to date of death or end of follow-up.
Progression Free Survival (PFS)
PFS will be assessed from the first drug given to date of progression, relapse, death or end of follow-up.
Full Information
NCT ID
NCT05809180
First Posted
March 22, 2023
Last Updated
April 18, 2023
Sponsor
The First Affiliated Hospital of Soochow University
1. Study Identification
Unique Protocol Identification Number
NCT05809180
Brief Title
Pro-miniCHOP-like Regimen for Treatment-naive Elderly Patients
Official Title
Prospective Exploratory Clinical Study of Orelabrutinib, Pomalidomide, Rituximab Combined With miniCHOP-like Regimen in Treatment-naive Elderly Patients With DLBCL
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2023 (Actual)
Primary Completion Date
July 3, 2025 (Anticipated)
Study Completion Date
July 3, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Soochow University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B Cell Lymphoma
Keywords
Diffuse Large B-Cell Lymphoma, Orelabrutinib, pomalidomide, Rituximab
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like
Arm Type
Experimental
Arm Description
Phase I(induction therapy): Patients receive Rituximab on day 1, Pomalidomide on days 1-7 and oral administration of Orelabrutinib per day.
Phase II(stratified response therapy):
Part A: (25% or more reduction): Patients receive Pro-miniCHOP-like regimen every 21 days for 6 cycles.(Rituximab on day 1, Pomalidomide on days 1-7, Orelabrutinib per day till progression or intolerant toxicity, Cyclophosphamide on day 2, Doxorubicin/Doxorubicin Liposome on day 2, Vindesine on day 2 and Dexamethasone on days 2-6).
Part B: (reduction less than 25%): Patients receive R-miniCHOP-like regimen every 21 days for 6 cycles.(Rituximab on day 1, Cyclophosphamide on day 2, Doxorubicin/Doxorubicin Liposome on day 2, Vindesine on day 2 and Dexamethasone on days 2-6).
Phase III(maintenance and follow-up): Patients take Pomalidomide orally on days 1-7 in a cycle of 21 days for 2 years.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
MabThera
Intervention Description
Rituximab 375mg/m2 ivgtt d1;
Intervention Type
Drug
Intervention Name(s)
Orelabrutinib
Other Intervention Name(s)
Yinuokai
Intervention Description
Orelabrutinib 150mg per day oral administration till progresses or intolerant toxicity;
Intervention Type
Drug
Intervention Name(s)
Pomalidomide
Other Intervention Name(s)
Anyve
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Pro-miniCHOP-like regimen
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
R-miniCHOP-like regimen
Intervention 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.
Primary Outcome Measure Information:
Title
Overall Response Rate(ORR) after Pro-miniCHOP-like regimen
Description
The rate of patients who achieved complete response and partial response after Pro-miniCHOP-like regimen.
Time Frame
At the end of cycle 6 (each cycle is 21 days)
Title
Complete Response Rate(CRR) after Pro-miniCHOP-like regimen
Description
The rate of patients who achieved complete response after Pro-miniCHOP-like regimen.
Time Frame
At the end of cycle 6 (each cycle is 21 days)
Secondary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events, treatment-related adverse events and serious adverse events
Description
The safety and tolerability of the therapeutic regimen measured by the incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events.
Time Frame
Initiation of study drug until 28 days after last dose
Title
Overall Response Rate(ORR) after Pro induction regimen
Description
The rate of patients who achieved complete response and partial response after Pro induction regimen.
Time Frame
At the end of a cycle 1 of induction therapy period (each cycle is 21 days)
Title
Complete Response Rate(CRR) after Pro induction regimen
Description
The rate of patients who achieved complete response after Pro induction regimen.
Time Frame
At the end of a cycle 1 of induction therapy period (each cycle is 21 days)
Title
Overall Survival (OS)
Description
OS will be assessed from the first drug given to date of death or end of follow-up.
Time Frame
Up to 2 years after the end of last patient's treatment
Title
Progression Free Survival (PFS)
Description
PFS will be assessed from the first drug given to date of progression, relapse, death or end of follow-up.
Time Frame
Up to 2 years after the end of last patient's treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhengming Jin
Phone
67781856
Email
jinzhengming519519@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Changju Qu
Phone
67781856
Email
qcj310@163.com
Facility Information:
Facility Name
the First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhengming Jin
Phone
+86 0512 67781856
Email
jinzhengming519519@163.com
First Name & Middle Initial & Last Name & Degree
Nana Ping
Phone
67781856
Email
ping.chengcheng@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All the data would be available at the First Affiliated Hospital and other researchers after the end of the study.
IPD Sharing Time Frame
After the end of the study
Learn more about this trial
Pro-miniCHOP-like Regimen for Treatment-naive Elderly Patients
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