Clinical trial NCT04152577: R2 and Combination Chemotherapy Versus R and Combination Chemotherapy in Newly Diagnosed Highly Aggressive B-NHL
Official title: Lenalidomide, Rituximab and Combination Chemotherapy Versus Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Highly Aggressive Non-Hodgkin B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Lymphoma, B-Cell
Keywords: Lenalidomide，rituximab，chemotherapy，highly aggressive B-NHL
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2019-11-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study，lenalidomide was added in the first-line treatment in the newly diagnosed highly invasively non-Hodgkin B-cell lymphoma. The R2-CHOP/R2-EPOCH etc was applied compared with the classical R-CHOP/R-EPOCH etc. The investigators tried to explore a more effective and safe treatment regimen for patients with high-risk B-cell lymphoma to improve the patient's poor prognosis.

Detailed description: Lymphoma has become one of the top ten malignant tumors, of which non-Hodgkin's B-cell lymphoma accounts for the majority. As the classic first-line treatment, the emergence of the R-CHOP program has resulted in clinical cures for more than 1/2 of patients with B-cell lymphoma. But for patients with highly aggressively B cell lymphoma, most of them still suffer from disease recurrences due to R-CHOP treatment alone.

In recent years, with the emergence of various new drugs, many researchers have tried to add new drugs to the classic R-CHOP program as a first-line treatment for non-Hodgkin B-cell lymphoma. As a new type of immunomodulator, lenalidomide was first approved for the treatment of multiple myeloma. In recent years, its role in refractory and relapsed B-cell lymphoma has gradually been recognized.

In 2015, Nowakowski et al. published a clinical study of 64 patients with diffuse large B-cell lymphoma who used R2-CHOP in first-line therapy. It was found that R2-CHOP does not improve R-CHOP in patients with GCB. The effective rate of treatment and the 2-year survival rate of patients, but for patients with non-GCB type DLBCL with poor prognosis, the addition of lenalidomide can greatly improve the remission rate of the disease and improve the poor prognosis of patients.

So, the investigators initiate this study to evaluate the efficacy of R2-CHOP/R2-EPOCH etc in newly diagnosed highly invasively non-Hodgkin B-cell lymphoma.

Eligibility criteria: Inclusion Criteria:

1. Newly diagnosed highly aggressively B-Cell Non-Hodgkin's lymphoma (NHL) confirmed by histopathology
2. The patient has at least ≥1 measurable tumor lesion with a diameter \>1.5 cm;
3. The patient has not undergone systemic chemotherapy or immunotherapy before;
4. ECOG score ≤ 2 points;
5. Liver and kidney function meets the following conditions: creatinine clearance rate ≥ 30ml / min, total bilirubin, AST and ALT ≤ 2.5 × ULN;
6. No history of malignant tumors within 5 years, except for cured carcinomas in situ such as basal cell carcinoma of the skin, cervical cancer, breast cancer, prostate cancer, etc.;
7. agree to take contraceptive measures during the trial period and within 3 months after the end of the trial;
8. Patients volunteered to participate in the study and signed informed consent.

Exclusion Criteria:

1. Serious cardiovascular and other important organs and blood, endocrine system lesions, and other history of malignant tumors;
2. Severe mental illness;
3. Pregnant or lactating women and men or women who intend to conceive in the near future;
4. The expected survival time is less than 6 months;
5. HBV, HCV or HIV infection or seropositive;
6. there are active infections;
7. Allergies or allergies to rituximab;
8. Compliance or poor follow-up;
9. Other circumstances that the investigator believes are not suitable for inclusion.

Primary outcomes:
measure: Overall Response Rate after 3 cycles
timeFrame: at the end of 3 cycles( each cycle is 21 days)
measure: Overall Response Rate after 6 cycles
timeFrame: at the end of 6 cycles( each cycle is 21 days)
Secondary outcomes:
measure: Progression free survival（PFS）
timeFrame: 2 years
measure: overall survival（OS）
timeFrame: 2 years
Other outcomes:
Locations:
city: Jin'an
country: China
facility: Department of Hematology, Provincial Hospital Affiliated to Shandong University
state: Shandong
Study officials:
affiliation: Shandong Provincial Hospital
name: Xin Wang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: