NCT04214626CompletedPhase 2
R-CHOP Combined With Lenalidomide in the First-line Treatment for Patients With Diffuse Large B Cell Lymphoma
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
Source: ClinicalTrials.gov · Last updated 19 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 26 Dec 2019
- Start date
- 5 Jan 2020
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Henan Cancer Hospital
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT04214626
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 60
- From 5 Jan 2020 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Serious surgery and trauma less than two weeks
- Vaccination with live attenuated vaccine less than 4 weeks
Other illness
- Other malignant tumor history or active malignant tumor need be treated
- Systemic therapy for serious acute/chronic infection
- Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
- 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
Other
- 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
- Researchers determine unsuited to participate in this trial
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.