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

NCT04214626 | Completed Phase 2 DMC

• 1 other identifier: HNSZLYYNHL02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diffuse Large B Cell Lymphoma

Keywords

Diffuse Large B Cell Lymphoma; R-CHOP; Lenalidomide

Outcome Measures

Primary Outcomes (1)

• 2-year progression-free survival

  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

  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

Secondary Outcomes (3)

• complete response rate

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

• 2-year overall survival

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

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

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

Other Outcomes (1)

• exploratory endpoint

  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

Study Arms (1)

R-CHOP regimen Combined With Lenalidomide

EXPERIMENTAL

Experimental: R-CHOP regimen Combined With Lenalidomide Induction Chemotherapy: Rituximab, 375mg/m2, Intravenous administration on day 0, Lenalidomide, 25mg oral administration on day 1 to 10, combined with regimen：CHOP (Cyclophosphamide, Epirubicin, Vincristine and Prednisone): repeated every 3 weeks, up to 6 cycles. Patients will exit and receive salvage treatment for the following situations: disease progression, stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops. 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. PS: Methotrexate, 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.

Drug: Rituximab; Drug: Lenalidomide; Drug: Cyclophosphamide; Drug: Epirubicin; Drug: Vincristine; Drug: Prednisone; Drug: Methotrexate

Interventions

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).

Also known as: RiTUXimab Injection

R-CHOP regimen Combined With Lenalidomide

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.

Also known as: Lenalidomide capsule

R-CHOP regimen Combined With Lenalidomide

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.

Also known as: Cyclophosphamide Injection

R-CHOP regimen Combined With Lenalidomide

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.

Also known as: Epirubicin hydrochloride

R-CHOP regimen Combined With Lenalidomide

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.

Also known as: Vincristine Injection

R-CHOP regimen Combined With Lenalidomide

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.

Also known as: Prednisone Oral Product

R-CHOP regimen Combined With Lenalidomide

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.

Also known as: Methotrexate Injectable Solution

R-CHOP regimen Combined With Lenalidomide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab; Lenalidomide; Cyclophosphamide; Epirubicin; Vincristine; Prednisone; Methotrexate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Aminopterin; Pterins; Pteridines

Study Officials

• Yanyan Liu, M.D. Ph.D

  Henan Cancer Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: R-CHOP combined with Lenalidomide in the first-line treatment for patients with medium to high risk/high risk DLBCL. The individuals with the same propensity score according to high-risk factors (IPI score, double-expressor and P53 protein positive) were set as external control group (1:1) treated with R-CHOP.

Study Record Dates

• First Submitted: December 26, 2019
• First Posted: January 2, 2020
• Study Start: January 5, 2020
• Primary Completion: December 31, 2023
• Study Completion: April 19, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-04

Locations

CN (1)