Treatment of Elderly Patients With Diffuse Large B-cell Lymphoma

Mingzhi Zhang

Status and phase: Unknown; Phase 4

Conditions: Diffuse Large B Cell Lymphoma

Treatments: Drug: (R)-CVP regimen; Drug: (R)-CHOP regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT03513601

hnslblzlzx2017-10

Details and patient eligibility

About

To explore the clinical features and efficacy evaluation of large b-cell lymphoma in old age.

Full description

The results of the analysis of the treatment of large b-cell lymphoma in old age were analyzed, and the treatment of large B cell lymphoma was provided.

Enrollment: 20 estimated patients

Sex: All

Ages: 70 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Above 70 years old，Pathology proved to be diffuse large B cell lymphoma，Estimated survival time > 3 months，None of chemotherapy contraindication;At least one measurable lesion according to RECIST;None of other serious diseases;Patients could be followed up;None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments.

volunteers who signed informed consent.

Exclusion criteria

• Currently undergoing chemotherapy, radiotherapy and targeted therapy (received chemotherapy within 3 weeks, received radiotherapy within 2 weeks, or has not recovered from any previous treatment of acute toxicity);Patients with uncontrolled medical problems (including active infection, uncontrolled diabetes, severe heart, liver, kidney dysfunction and interstitial pneumonia, etc.); Pregnant or lactating women;Serious medical illness likely to interfere with participation;Chemotherapy contraindication such as cachexia; patients with other malignancies previously;Serious infection;The evidence of peripheral nervous disorder or dysphrenia; patients estimated to be unsuitable by investigator.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

(R)-CHOP regimen

Experimental group

Description:

(R)-CHOP regimen((rituximab)，cyclophosphamide，epirubicin，vincristine and prednisone)，(rituximab 375mg/m2 d0 ivgtt),cyclophosphamide 750mg/m2 d1、8 ivgtt,epirubicin 50mg/m2 d1、8 ivgtt,vincristine 2mg d1、8 ivgtt,prednisone 60mg d1-5 po.Every 21 days for one cycle and six cycles are required. Efficacy was evaluated every two cycles.

Treatment:

Drug: (R)-CHOP regimen

(R)-CVP regimen

Experimental group

Description:

(R)-CVP regimen((rituximab)，cyclophosphamide，vincristine and prednisone) The dose of the chemical was reduced by 20%，(rituximab 375mg/m2 d0 ivgtt),cyclophosphamide 750mg/m2 d1、8 ivgtt,vincristine 2mg d1、8 ivgtt,prednisone 60mg d1-5 po.Every 21 days for one cycle and one or two cycles are required. Efficacy was evaluated every two cycles. Subsequent (rituximab 375mg/m2 d0 ivgtt)， oral cyclophosphamide .

Treatment:

Drug: (R)-CVP regimen