relapsed or refractory non-Hodgkin's lymphoma
Conditions
Interventions
GCD +/- R therapy
Gemcitabine 1000mg/sqm Day 1,8
Carboplatin AUC5 Day 1
Dexamethasone 40mg Day 1-4
*if CD 20 is positive
Rituximab 375mg/sqm Day 8
Sponsors
Tsurumi Hisashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients have pathologically confirmed refractory or relapsed non-Hodgkin lymphoma. 2) Patients had received prior treatment of rituximab in combination with CHOP or THP-COP. 3) Patients aged >= 18 years. 4) ECOG performance status of 0-2 5) Patients have measurable lesion. 6) Patients without interstitial pneumonia or pulmonary fibrosis evidenced by chest X-ray and/or chest CT. 7) Patients have a life expectancy > 12 weeks. 8) Written informed consent. 9) Patients meet all following standard. - Absolute neutrophil count >= 1,000/mm3 - Hemoglobin >= 8.0 g/dL - Platelet count >= 75,000/mm3 - AST and ALT < 2.5 times facility criteria. - Total bilirubin < 2.5 times facility criteria.
Exclusion criteria
Exclusion criteria: 1) Patients have CNS invasion. 2) HIV antibody positive. 3) Patients have interstitial pneumonia or pulmonary fibrosis evidenced by chest X-ray and/or chest CT. 4) Patients undergoing chest radiotherapy. 5) Patients have major heart/lung disorders, or uncontrolled diabetes mellitus. 6) Patients are pregnant or lactating women. Patients cannot or will not use birth control during the treatment. 7) Patients have active other malignant diseases. 8) Patients have severe allergic symptoms. 9) Patients have chemotherapy resistant lymphoma. 10) Inadequate for clinical trial entry by the attending physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate overall survival progression free survival safety peripheral blood stem cell harvest (transplant case) | — |
Contacts
Public ContactNakamura Nobuhiko
Gifu University Hospital
Outcome results
None listed