relapsed or refractory non-Hodgkin lymphoma
Conditions
Interventions
Gemcitabine 1000mg/m2, Day1, 8 Dexamethasone 40mg/body, Day1-4 Cisplatin 75mg/m2, Day1 Rituximab 375mg/m2, Day1, 8 Up to 8 cycles
Sponsors
Hiroshima University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) non-Hodgkin lymphoma(aged 20 or older) 2) measurable lesion(s) 3) antecedent treatment(s) 4) 6 months or more in estimated survival 5) 0-2 in Performance Status 6) well preserved organic function 7) written consent
Exclusion criteria
Exclusion criteria: 1) Received a gemcitabine previously 2) Allergic experience to rituximab or mouse proteins in the case of administration of rituximab 3) Pulmonary fibrosis or interstitial pneumonia detected within 28 days 4) Serious heart disease 5) Serious digestive symptoms 6) Body cavity fluid requiring treatment 7) Severe bone marrow suppression 8) Active infection 9) Serologically positive for HBsAg, HCVAb, or HIVAb 10) Severe bleeding tendency 11) Symptomatic brain metastasis 12) Critical complication 13) Serious mental disease 14) Active malignancy concomitantly existed 15) Auto immune hemolytic anemia 16) Lactating women, pregnant women and women suspected of being pregnant 17) Disagreement on intercourse without contraception 18) Ineligibility owing to the decision of doctor involved in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Promary endpoint Overall responsive rate Primary endpoint is determined to be an overall responsive rate of GDP therapy evaluated according to IWRC. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints 1) CRrate 2) Progression free survival 3) Therapeutic efficacy and safety of GDP therapy are estimated compared with those of historical control. 4) Adverse effect | — |
Countries
Japan
Contacts
Public ContactKeichiro Mihara
Hiroshima University Dept of Hematology and Oncology
Outcome results
None listed