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

NCT ID: NCT05809180

Last Updated: 2023-04-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-04
• Study Completion Date: 2026-07-03

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.

Conditions

Diffuse Large B Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like

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.

Group Type: EXPERIMENTAL

Rituximab

Intervention Type: DRUG

Rituximab 375mg/m2 ivgtt d1;

Orelabrutinib

Intervention Type: DRUG

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

Pomalidomide

Intervention Type: DRUG

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.

Pro-miniCHOP-like regimen

Intervention Type: DRUG

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.

R-miniCHOP-like regimen

Intervention Type: DRUG

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.

Interventions

Rituximab

Rituximab 375mg/m2 ivgtt d1;

Intervention Type: DRUG

Orelabrutinib

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

Intervention Type: DRUG

Pomalidomide

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

Pro-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.

Intervention Type: DRUG

R-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.

Intervention Type: DRUG

Other Intervention Names

MabThera; Yinuokai; Anyve

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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhengming Jin

Role: CONTACT

jinzhengming519519@163.com

67781856

Changju Qu

Role: CONTACT

qcj310@163.com

67781856

Facility Contacts

Zhengming Jin

Role: primary

jinzhengming519519@163.com

+86 0512 67781856

Nana Ping

Role: backup

ping.chengcheng@163.com

67781856

Other Identifiers

Jinzm 005

Identifier Type: -

Identifier Source: org_study_id