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NCT Number: NCT06674096

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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

Treatment and study plan

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

Primary outcomes

  1. PFS

    Time frame: 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

    Progression Free Survival

Secondary outcomes

  1. ORR

    Time frame: 21days after the end of treatment

    overall response rate

  2. CRR

    Time frame: 21days after the end of treatment

    complete response rate

  3. OS

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

    Overall Survival

  4. AE and SAE

    Time frame: From date of first day of treatment until 30 day after last treatment

    Adverse event and serious adverse event

  5. Performance status

    Time frame: 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

    Assess the patient's performance status according to the Barthel index. Patients will be classified into 5 scales with the score ranging from 0 to 100: 0-20 points=extremely severe functional impairment; 25-45 points=severe functional impairment; 50-70 points=moderate functional impairment; 75-95 points=mild functional impairment; 100 points=normal. Higher scores mean a better outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Registry information

Official study title

Rituximab,Lenalidomide and Chidamide Followed by CR-CHOP in Elderly Patients with Newly-diagnosed Double-expressor Lymphoma

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Nov 5, 2024
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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