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

NCT06674096 | Recruiting Phase 2

• 1 other identifier: RLC-CRCHOP
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Double-expressor Lymphoma

Keywords

DLBCL; DEL; rituximab; lenalidomide; chidamide; chemo-free

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression Free Survival

  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 (5)

• ORR

  21days after the end of treatment

• CRR

  21days after the end of treatment

• OS

  : From date of first day of treatment until the date of first documented date of death from any cause, assessed up to 24 months

• AE and SAE

  From date of first day of treatment until 30 day after last treatment

• Performance status

  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

Study Arms (1)

RLC-CRCHOP

EXPERIMENTAL

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

Drug: RLC-CRCHOP

Interventions

RLC-CRCHOP 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

RLC-CRCHOP

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \. 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.
• \. 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.

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Central Study Contacts

Chen Xi

CONTACT

+8617816890591; zjuchenxi@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief director of Lymphoma Department

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 5, 2024
• Study Start: November 6, 2024
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)