RLC Followed by CR-CHOP in Elderly Patients with Newly-diagnosed DEL

NCT ID: NCT06674096

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-06
• Study Completion Date: 2030-06-30

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.

Conditions

Double-expressor Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RLC-CRCHOP

Introduction treatment: Rituximab, lenalidomide, chidamide for 2 cycles:

rituximab 375mg/m2, d1, lenalidomide 10mg qd d1-14, chidamide 20mg, d1,4,8,11.

Immunochemtherapy phase: CR CHOP for 4 cycles: chidamide 20mg d1,4,8,11,rituximab 375mg/m2 d0, cyclophosphamide: 750mg/m2 d1, epirubicin: 75mg/ m2 d1 (or liposomal doxorubicin 35mg/m2 d1), vindesine 4mg d1, prednisone: 100mg, d1-5.

maintenance treatment period: chidamide d1,4,8,11

Group Type: EXPERIMENTAL

RLC-CRCHOP

Intervention Type: DRUG

Introduction treatment: Rituximab, lenalidomide, chidamide for 2 cycles:

rituximab 375mg/m2, d1, lenalidomide 10mg qd d1-14, chidamide 20mg, d1,4,8,11.

Immunochemtherapy phase: CR CHOP for 4 cycles: chidamide 20mg d1,4,8,11,rituximab 375mg/m2 d0, cyclophosphamide: 750mg/m2 d1, epirubicin: 75mg/ m2 d1 (or liposomal doxorubicin 35mg/m2 d1), vindesine 4mg d1, prednisone: 100mg, d1-5.

maintenance treatment period: chidamide d1,4,8,11

Interventions

RLC-CRCHOP

Introduction treatment: Rituximab, lenalidomide, chidamide for 2 cycles:

rituximab 375mg/m2, d1, lenalidomide 10mg qd d1-14, chidamide 20mg, d1,4,8,11.

Immunochemtherapy phase: CR CHOP for 4 cycles: chidamide 20mg d1,4,8,11,rituximab 375mg/m2 d0, cyclophosphamide: 750mg/m2 d1, epirubicin: 75mg/ m2 d1 (or liposomal doxorubicin 35mg/m2 d1), vindesine 4mg d1, prednisone: 100mg, d1-5.

maintenance treatment period: chidamide d1,4,8,11

Intervention Type: DRUG

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yang haiyan

Chief director of Lymphoma Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chen Xi

Role: CONTACT

zjuchenxi@126.com

+8617816890591

Facility Contacts

Haiyan Yang, PhD

Role: primary

yanghy@zjcc.org.cn

0086-571-88122192

Xi Chen, MD

Role: backup

zjuchenxi@126.com

0086-571-88122192

Xi Chen, MD

Role: backup

Other Identifiers

RLC-CRCHOP

Identifier Type: -

Identifier Source: org_study_id