Diffuse large B cell lymphoma
Conditions
Interventions
control group:R-CHOP-21 therapy
experimental group:rhGM-CSF plus R-CHOP-21 therapy
Sponsors
the First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Previously untreated DLBCL histologically; 2. Older than 18 years; 3. At least one measurable lesion defined as one lesion larger than 1.5cm or two lesion more than 1.0cm; 4. Life expectancy of longer than 4 months; 5. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. History of allergic to Rituximab, rhGM-CSF or e.coli products; 2. Uncontrollable infections; 3. Abnormallaboratory values: Serum creatinine Cr more than 177 mol/L, Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 2.5 times the upper linit of normal (ULN), total bilirubin (TBIL) more than 34mol/L, abnormal cardiac function, left ventricular ejection fraction (LVEF) less than 50%, abnormal pulmonary function, FEV1 less than 60% or carbon monoxide diffusion function less than 55%; 4. Positive test results for HIV, hepatitis c or T lymphotrophic virus (type 1 or 2), active hepatitis B infection or positive HBsAg; 5. Diabetes or immune deficiency; 6. History of other malignancy; 7. Pregnancy or lactation; 8. Subjects who do not meet with the selected standards.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| total remission rate, remission time and overall survival; | — |
Countries
China
Contacts
Public ContactDepei Wu
Outcome results
None listed