Clinical trial NCT04214626: R-CHOP Combined With Lenalidomide in the First-line Treatment for Patients With Diffuse Large B Cell Lymphoma
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diffuse Large B Cell Lymphoma
Keywords: Diffuse Large B Cell Lymphoma
R-CHOP
Lenalidomide
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2020-01-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age between 18 to 70 years old (including 18 and 70)
2. Diagnosed as diffuse large B cell lymphoma
3. 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%)
4. No receiving chemotherapy before enrollment
5. Having at least one measurable lesions
6. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2
7. Life expectancy no less than 3 months
8. enough main organ function
9. 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
10. Agreeing to sign the written informed consents

Exclusion Criteria:

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

Primary outcomes:
measure: 2-year progression-free survival
timeFrame: 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:
measure: complete response rate
timeFrame: every 6 weeks from the day of the first cycle of induction chemotherapy treatment, up to 6 months after last patient's enrollment
measure: 2-year overall survival
timeFrame: from date of the first cycle of treatment to the date of death from any cause, assessed up to 2 years
measure: incidence and relationship with study drugs of grade 3-4 adverse events
timeFrame: from the date of the first cycle of treatment to 6 months after last patient's enrollment
Other outcomes:
measure: exploratory endpoint
timeFrame: 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
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Yanyan Liu, M.D. Ph.D
role: STUDY_DIRECTOR
References: