Clinical trial NCT05809180: Pro-miniCHOP-like Regimen for Treatment-naive Elderly Patients
Official title: Prospective Exploratory Clinical Study of Orelabrutinib, Pomalidomide, Rituximab Combined With miniCHOP-like Regimen in Treatment-naive Elderly Patients With DLBCL
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diffuse Large B Cell Lymphoma
Keywords: Diffuse Large B-Cell Lymphoma
Orelabrutinib
pomalidomide
Rituximab
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 35
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Overall Response Rate(ORR) after Pro-miniCHOP-like regimen
timeFrame: At the end of cycle 6 (each cycle is 21 days)
measure: Complete Response Rate(CRR) after Pro-miniCHOP-like regimen
timeFrame: At the end of cycle 6 (each cycle is 21 days)
Secondary outcomes:
measure: Incidence of treatment-emergent adverse events, treatment-related adverse events and serious adverse events
timeFrame: Initiation of study drug until 28 days after last dose
measure: Overall Response Rate(ORR) after Pro induction regimen
timeFrame: At the end of a cycle 1 of induction therapy period (each cycle is 21 days)
measure: Complete Response Rate(CRR) after Pro induction regimen
timeFrame: At the end of a cycle 1 of induction therapy period (each cycle is 21 days)
measure: Overall Survival (OS)
timeFrame: Up to 2 years after the end of last patient's treatment
measure: Progression Free Survival (PFS)
timeFrame: Up to 2 years after the end of last patient's treatment
Other outcomes:
Locations:
city: Suzhou
country: China
facility: the First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
References: