Clinical trial NCT06674096: RLC Followed by CR-CHOP in Elderly Patients with Newly-diagnosed DEL
Official title: Rituximab，Lenalidomide and Chidamide Followed by CR-CHOP in Elderly Patients with Newly-diagnosed Double-expressor Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Double-expressor Lymphoma
Keywords: DLBCL
DEL
rituximab
lenalidomide
chidamide
chemo-free
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 44
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, single-arm, multicenter clinical study to evaluate the efficacy and safety of chidamide, rituximab combined with lenalidomide sequential immunochemotherapy in the treatment of newly diagnosed elderly double-expressor diffuse large B-cell lymphoma.

Detailed description: It is divided into 4 stages: screening period, induction therapy period, immunochemotherapy period and maintenance therapy period. The screening period was 28 days before the first dose. Introduction treatment period: Enrolled subjects received RLC regimen every 21 days for a cycle of 2 cycles. Immunochemotherapy phase: CR-miniCHOP regimen was administered after the completion of the introduction therapy phase. Every 21 days for a cycle, treatment for 4 cycles. Patients who achieved CR with induction therapy entered the maintenance treatment period, receiving 20 mg of chidamide d1,4,8,11 recommended 8 cycles. Patients who did not achieve CR were discontinued from the study and treated at the discretion of their physician.

Eligibility criteria: Inclusion Criteria:

* 1. Untreated DLBCL patients confirmed by histopathology 2. Immunohistochemistry showed positive expression of MYC and BCL2 protein (double expressor lymphoma, MYC≥40%, BCL2≥50%) 3. age over 70 years old or age ≥65 years old and ECOG score ≥2 points, both male and female 4. Having at least one evaluable lesion, defined as having at least one lymphadenopathy with a maximum diameter \> 1.5 cm, or at least one extranodal lesion with a maximum diameter \> 1.0 cm, and at least two vertical diameters that can be accurately measured.

  5. ECOG PS≤3 6. Expected survival time ≥3 months 7. voluntary participation in clinical research; Fully understand and understand the study and sign the informed consent; Willingness to follow and ability to complete all research steps.

Exclusion Criteria:

* 1. The pathological subtypes were PCNSL, PMBCL, EBV-positive DLBCL and HGBL 2. Hemophagocytic syndrome accompanied the diagnosis 3. Central nervous system involvement is secondary to lymphoma 4. Are participating in other clinical studies, or the first study drug is administered less than 4 weeks after the end of treatment in the previous clinical study 5. HIV infection 6. Major surgery was performed within 28 days prior to study start 7. Any active infection that required systematic anti-infective therapy developed within 14 days prior to study initiation 8. The patients considered by the investigator to be unsuitable for participating in this study

Primary outcomes:
measure: PFS
timeFrame: From date of first day of treatment until the date of first documented date of disease progression or death from any cause, assessed up to 24 months
Secondary outcomes:
measure: ORR
timeFrame: 21days after the end of treatment
measure: CRR
timeFrame: 21days after the end of treatment
measure: OS
timeFrame: : From date of first day of treatment until the date of first documented date of death from any cause, assessed up to 24 months
measure: AE and SAE
timeFrame: From date of first day of treatment until 30 day after last treatment
measure: Performance status
timeFrame: At screening period, after 2 cycles of ZR2 regimen(each cycle is 21 days), after 2 cycles of RCHOP regimen(each cycle is 21 days) and 21days after the end of treatment
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: