Diffuse Large B Cell Lymphoma
Conditions
Keywords
Diffuse Large B-Cell Lymphoma, Orelabrutinib, pomalidomide, Rituximab
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.
Interventions
DRUGRituximab
Rituximab 375mg/m2 ivgtt d1;
DRUGOrelabrutinib
Orelabrutinib 150mg per day oral administration till progresses or intolerant toxicity;
DRUGPomalidomide
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.
DRUGPro-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.
DRUGR-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.
Sponsors
The First Affiliated Hospital of Soochow University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactZhengming Jin
Backup ContactChangju Qu
Outcome results
None listed