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

Henan Cancer Hospital

Status and phase: Completed; Phase 2

Conditions: Diffuse Large B Cell Lymphoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04214626

HNSZLYYNHL02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

R-CHOP regimen Combined With Lenalidomide

Experimental group

Description:

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.

Treatment:

Drug: Prednisone

Drug: Epirubicin

Drug: Vincristine

Drug: Rituximab

Drug: Cyclophosphamide

Drug: Lenalidomide

Drug: Methotrexate