Treatment of Diffuse Large B Cell Lymphoma

Mingzhi Zhang

Status and phase: Unknown; Phase 4

Conditions: Diffuse Large B Cell Lymphoma

Treatments: Drug: CHOP regimen; Drug: Yangzhengxiaoji capsule combined with CHOP regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT01949818

hnslblzlzx2011-4

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of Yangzhengxiaoji Capsule Combination Chemotherapy for III/IV Diffuse Large B Cell Lymphoma.

Enrollment: 120 estimated patients

Sex: All

Ages: 14 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age range 14-70 years old; ECOG performance status 0-2; Estimated survival time > 3 months Histological confirmed Diffuse large B cell lymphoma(III/IV) None of chemotherapy or radiotherapy has been previously used None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤ 1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L At least one measurable lesion None of other serious diseases, cardiopulmonary function is normal Pregnancy test of women at reproductive age must be negative 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.

Exclusion criteria

• Disagreement on blood sample collection Patients allergic of any of drug in this regimen or with metabolic disorder Pregnant or lactating women Serious medical illness likely to interfere with participation Serious infection Primitive or secondary tumors of central nervous system Chemotherapy or radiotherapy contraindication The evidence of CNS metastasis History of peripheral nervous disorder or dysphrenia patients participating in other clinical trials patients taking other antitumor drugs patients estimated to be unsuitable by investigation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Yangzhengxiaoji Capsule combined with CHOP regimen

Experimental group

Description:

Yangzhengxiaoji Capsule combined with CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen

Treatment:

Drug: Yangzhengxiaoji capsule combined with CHOP regimen

CHOP regimen

Experimental group

Description:

CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen

Treatment:

Drug: CHOP regimen