Pro-miniCHOP-like Regimen for Treatment-naive Elderly Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like Phase I(induction therapy): Patients receive Rituximab on day 1, Pomalidomide on days 1-7 and oral administration of Orelabrutinib per day. 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). 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
Rituximab 375mg/m2 ivgtt d1;
Other Names:
Drug: Orelabrutinib
Orelabrutinib 150mg per day oral administration till progresses or intolerant toxicity;
Other Names:
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.
Other Names:
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.
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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 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 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histopathologically or Cytologically confirmed newly diagnosed untreated DLBCL;
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There is at least one radiographically measurable lesion (i.e., ≥ 15mm in diameter);
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Age ≥ 70 years;
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Life expectancy >3 months;
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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).
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Written informed consent obtained from the subject.
Exclusion Criteria:
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Patients with severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine > 3 times the upper limit of normal);
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Patients with organic heart disease with clinical symptoms or cardiac dysfunction (NYHA grade ≥2);
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Uncontrolled active infection;
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Patients with central nervous system DLBCL;
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A history of vascular embolism;
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Co-existence of other tumors;
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Systemic corticosteroid therapy is needed;
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Any other psychological conditions that prevent patients from participating in the study or signing the informed consent form.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | the First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China | 215006 |
Sponsors and Collaborators
- The First Affiliated Hospital of Soochow University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Jinzm 005