GHG-GCD
- Conditions
- relapsed or refractory non-Hodgkin's lymphoma
- Registration Number
- JPRN-jRCT1041230085
- Lead Sponsor
- Tsurumi Hisashi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method complete response rate
- Secondary Outcome Measures
Name Time Method overall response rate<br>overall survival<br>progression free survival<br>safety<br>peripheral blood stem cell harvest (transplant case)