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NCT Number: NCT04214626

R-CHOP Combined With Lenalidomide in the First-line Treatment for Patients With Diffuse Large B Cell Lymphoma

This is a prospective single-arm, multi-center, phase II clinical trial to observe the efficacy and safety of R-CHOP (Rituximab-Cyclophosphamide, Epirubicin, Vincristine and Prednisone) combined with lenalidomide in the first-line treatment for patients with medium to high risk/high risk diffuse large B cell lymphoma.

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Key information

Conditions

Diffuse Large B Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, China

About this study

Diffuse large B cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma (NHL). Currently, R-CHOP is world-widely used in the first-line treatment for DLBCL. There are about one second of patients suffering relapse and drug resistance. Lenalidomide is an analog of thalidomide, the mechanism of anti-tumor action has not been fully elucidated. Lenalidomide has been proved to inhibit the proliferation of tumor cells in certain hematopoietic systems. At present, it has been approved for the treatment of multiple myeloma with good efficacy and safety. The goal of our trial is to assess the efficacy and safety of R-CHOP combined with lenalidomide in the first-line treatment for patients with medium to high risk/high risk diffuse large B cell lymphoma.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 18 to 70 years old (including 18 and 70)
  • Diagnosed as diffuse large B cell lymphoma
  • Subjects must be untreated (medium to high risk/high risk: International Prognostic Index (IPI) score 3-5 or aaIPI score 2-3/ Immunohistochemical staining of double expression (BCL2 ≥ 50% and C-MYC ≥ 40%) or P53 protein mutation positive ≥ 50%)
  • No receiving chemotherapy before enrollment
  • Having at least one measurable lesions
  • World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2
  • Life expectancy no less than 3 months
  • enough main organ function
  • Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
  • Agreeing to sign the written informed consents

Exclusion criteria

  • Diagnosed as high-grade B-cell lymphoma, including non-specified and double-strike or triple-strike
  • Diagnosed as grey-zone lymphoma
  • Diagnosed as central nervous system lymphoma
  • Diagnosed as primary mediastinal large B-cell lymphoma
  • Diagnosed as CD20 negative diffuse large B-cell lymphoma
  • Other malignant tumor history or active malignant tumor need be treated
  • Serious surgery and trauma less than two weeks
  • Systemic therapy for serious acute/chronic infection
  • Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
  • Vaccination with live attenuated vaccine less than 4 weeks
  • HIV-positive, AIDS patients and untreated active hepatitis
  • Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months
  • Patients with a history of mental illness
  • Researchers determine unsuited to participate in this trial

Treatment and study plan

Rituximab

Drug

Induction Chemotherapy: 375mg/m2, Intravenous administration on day 0 of each 3-week cycle until disease progression, stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.

Maintenance Treatment for patients with CR after 6 cycles: Rituximab, 375mg/m2, Intravenous administration on day 0 repeated every 3 weeks until disease progression or unacceptable toxicity develops, up to 2 cycles (Total 8 cycles).

Other names: RiTUXimab Injection

Lenalidomide

Drug

Induction Chemotherapy: 25mg, oral administration on day 1 to 10 of each 3-week cycle until disease progression, stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.

Other names: Lenalidomide capsule

Cyclophosphamide

Drug

Induction Chemotherapy: 750mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression, stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.

Other names: Cyclophosphamide Injection

Epirubicin

Drug

Induction Chemotherapy: 70mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression, stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.

Other names: Epirubicin hydrochloride

Vincristine

Drug

Induction Chemotherapy: 1.4mg/m2 (Max: 2mg), Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.

Other names: Vincristine Injection

Prednisone

Drug

Induction Chemotherapy: 100mg, oral administration on day 1 to 5 of each 3-week cycle until disease progression/stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.

Other names: Prednisone Oral Product

methotrexate

Drug

Induction Chemotherapy: 1g/m2, Intravenous administration on day 3 of each 3-week cycle from 2 to 5 cycles for patients with high recurrence risk of the central nervous system.

Other names: Methotrexate Injectable Solution

Primary outcomes

  1. 2-year progression-free survival

    Time frame: from the day of the first cycle of treatment to the date of confirmed progressive disease or death, whichever occurs first, up to 2 years after last patient's enrollment

    the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurs first

Secondary outcomes

  1. complete response rate

    Time frame: every 6 weeks from the day of the first cycle of induction chemotherapy treatment, up to 6 months after last patient's enrollment

    the total proportion of patients with complete response (CR)

  2. 2-year overall survival

    Time frame: from date of the first cycle of treatment to the date of death from any cause, assessed up to 2 years

    from date of first day of treatment to the date of death by any cause

  3. incidence and relationship with study drugs of grade 3-4 adverse events

    Time frame: from the date of the first cycle of treatment to 6 months after last patient's enrollment

    the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v4.03)

Other outcomes

  1. exploratory endpoint

    Time frame: from the day of the first cycle of treatment to the date of confirmed progressive disease or death, whichever occurs first, up to 2 years after last patient's enrollment

    The correlation between hotspot driven gene mutations and complete response rate, PFS, or OS

Sponsors and collaborators

Lead sponsor

Henan Cancer Hospital

Other Gov

Registry information

Official study title

A Single-arm, Multi-center, Phase II Clinical Trial of R-CHOP Combined With Lenalidomide in the First-line Treatment for Patients With Medium to High Risk/High Risk Diffuse Large B Cell Lymphoma

Important dates

Study start
2020
Primary completion
2023
Study completion
2025
First posted
Jan 2, 2020
Registry last updated
Nov 19, 2025

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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