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

Diffuse Large B Cell Lymphoma Clinical Trial

Official title:

Prospective Exploratory Clinical Study of Orelabrutinib, Pomalidomide, Rituximab Combined With miniCHOP-like Regimen in Treatment-naive Elderly Patients With DLBCL

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05809180
• Other study ID #: Jinzm 005
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2023
• Est. completion date: July 3, 2026

Study information

• Verified date: February 2023
• Source: The First Affiliated Hospital of Soochow University
• Contact: Zhengming Jin
• Phone: 67781856
• Email: jinzhengming519519[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: July 3, 2026
• Est. primary completion date: July 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Rituximab
Rituximab 375mg/m2 ivgtt d1;
• Orelabrutinib
Orelabrutinib 150mg per day oral administration till progresses or intolerant toxicity;
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the end of cycle 6 (each cycle is 21 days)
Primary	Complete Response Rate(CRR) after Pro-miniCHOP-like regimen	The rate of patients who achieved complete response after Pro-miniCHOP-like regimen.	At the end of cycle 6 (each cycle is 21 days)
Secondary	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.	Initiation of study drug until 28 days after last dose
Secondary	Overall Response Rate(ORR) after Pro induction regimen	The rate of patients who achieved complete response and partial response after Pro induction regimen.	At the end of a cycle 1 of induction therapy period (each cycle is 21 days)
Secondary	Complete Response Rate(CRR) after Pro induction regimen	The rate of patients who achieved complete response after Pro induction regimen.	At the end of a cycle 1 of induction therapy period (each cycle is 21 days)
Secondary	Overall Survival (OS)	OS will be assessed from the first drug given to date of death or end of follow-up.	Up to 2 years after the end of last patient's treatment
Secondary	Progression Free Survival (PFS)	PFS will be assessed from the first drug given to date of progression, relapse, death or end of follow-up.	Up to 2 years after the end of last patient's treatment