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

Not Applicable

Recruiting

• Conditions: Diffuse Large B Cell Lymphoma
• Interventions: Drug: Rituximab; Drug: Orelabrutinib; Drug: Pomalidomide; Drug: Pro-miniCHOP-like regimen; Drug: R-miniCHOP-like regimen

• Registration Number: NCT05809180
• Lead Sponsor: The First Affiliated Hospital of Soochow University

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.

Study Timeline

• Study Start: 2023-01-04
• Status Verified: 2023-02
• Study First Submitted: 2023-03-22
• Study First Submitted QC: 2023-04-10
• Study First Posted: 2023-04-12
• Last Update Submitted: 2023-04-18
• Last Update Posted: 2023-04-20
• Primary Completion: 2025-07-03
• Study Completion: 2026-07-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like	R-miniCHOP-like regimen	1. Phase I(induction therapy): Patients receive Rituximab on day 1, Pomalidomide on days 1-7 and oral administration of Orelabrutinib per day. 2. 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). 3. Phase III(maintenance and follow-up): Patients take Pomalidomide orally on days 1-7 in a cycle of 21 days for 2 years.
rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like	Pro-miniCHOP-like regimen	1. Phase I(induction therapy): Patients receive Rituximab on day 1, Pomalidomide on days 1-7 and oral administration of Orelabrutinib per day. 2. 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). 3. Phase III(maintenance and follow-up): Patients take Pomalidomide orally on days 1-7 in a cycle of 21 days for 2 years.
rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like	Pomalidomide	1. Phase I(induction therapy): Patients receive Rituximab on day 1, Pomalidomide on days 1-7 and oral administration of Orelabrutinib per day. 2. 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). 3. Phase III(maintenance and follow-up): Patients take Pomalidomide orally on days 1-7 in a cycle of 21 days for 2 years.
rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like	Orelabrutinib	1. Phase I(induction therapy): Patients receive Rituximab on day 1, Pomalidomide on days 1-7 and oral administration of Orelabrutinib per day. 2. 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). 3. Phase III(maintenance and follow-up): Patients take Pomalidomide orally on days 1-7 in a cycle of 21 days for 2 years.
rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like	Rituximab	1. Phase I(induction therapy): Patients receive Rituximab on day 1, Pomalidomide on days 1-7 and oral administration of Orelabrutinib per day. 2. 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). 3. Phase III(maintenance and follow-up): Patients take Pomalidomide orally on days 1-7 in a cycle of 21 days for 2 years.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate(ORR) after Pro-miniCHOP-like regimen	At the end of cycle 6 (each cycle is 21 days)	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	At the end of cycle 6 (each cycle is 21 days)	The rate of patients who achieved complete response after Pro-miniCHOP-like regimen.

Secondary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events, treatment-related adverse events and serious adverse events	Initiation of study drug until 28 days after last dose	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	At the end of a cycle 1 of induction therapy period (each cycle is 21 days)	The rate of patients who achieved complete response and partial response after Pro induction regimen.
Complete Response Rate(CRR) after Pro induction regimen	At the end of a cycle 1 of induction therapy period (each cycle is 21 days)	The rate of patients who achieved complete response after Pro induction regimen.
Overall Survival (OS)	Up to 2 years after the end of last patient's treatment	OS will be assessed from the first drug given to date of death or end of follow-up.
Progression Free Survival (PFS)	Up to 2 years after the end of last patient's treatment	PFS will be assessed from the first drug given to date of progression, relapse, death or end of follow-up.

Trial Locations

Locations (1)

the First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China