An interventional study of Rituximab and Orelabrutinib in Diffuse Large B Cell Lymphoma, sponsored by The First Affiliated Hospital of Soochow University. Recruiting at 1 site in China. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2023-04-20.
Sponsored by The First Affiliated Hospital of Soochow University · Not applicable, Interventional, and Treatment
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.
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.
1,411 studies on the registry are indexed under Lymphoma, B-Cell; 329 are open to participants now.
This study's planned enrollment of 35 is close to the median of 36 across 1,218 interventional studies indexed under Lymphoma, B-Cell.
Browse Lymphoma, B-Cell studies →The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Rituximab · Drug: Orelabrutinib · Drug: Pomalidomide · Drug: Pro-miniCHOP-like regimen · Drug: R-miniCHOP-like regimen
Rituximab 375mg/m2 ivgtt d1;
Also known as: MabThera
Orelabrutinib 150mg per day oral administration till progresses or intolerant toxicity;
Also known as: Yinuokai
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.
Also known as: Anyve
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.
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.
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.
Time frame: At the end of cycle 6 (each cycle is 21 days)
Complete Response Rate(CRR) after Pro-miniCHOP-like regimen
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)
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.
Time frame: Initiation of study drug until 28 days after last dose
Overall Response Rate(ORR) after Pro induction regimen
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)
Complete Response Rate(CRR) after Pro induction regimen
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)
Overall Survival (OS)
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
Progression Free Survival (PFS)
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
Plan to share: Yes — All the data would be available at the First Affiliated Hospital and other researchers after the end of the study.
Supporting information: Study protocol, Sap
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