Rituximab combined with gemcitabine, dexamethasone, and cisplatin in elderly patients with relapsed or refractory diffuse large B-cell lymphoma
- Conditions
- Diffuse large B-cell lymphoma
- Registration Number
- JPRN-UMIN000015492
- Lead Sponsor
- ational Hospital Organization Kyushu Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 42
Not provided
Patients who fulfill any of the following criteria are not eligible for admission to the study: 1)B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and Burkitt lymphoma (intermediate DLBCL/BL) or Burkitt lymphoma 2)Testicular lymphoma or central nervous system involvement by lymphoma. Patients diagnosed with CNS disease at the time of relapse (on-study) are not eligible. Patients diagnosed with CNS disease at initial presentation who achieved and maintained CNS CR at the time of relapse are eligible. Lumbar puncture must be done in this case prior to study entry to demonstrate CNS CR status. Tests to investigate CNS involvement are required otherwise only if clinically indicated. 3)Uncontrolled liver, kidney, cardiac or pulmonary dysfunction, or diabetes mellitus or hypertension. 4)Interstitial lung disease or pulmonary fibrosis. 5)Uncontrolled bacterial, fungal, or viral infection. 6)Patients with a history of cardiac dysfunction or cardiovascular disease (< 6 months at diagnosis). 7)Patients with a history of other malignancies, except: curatively treated in-situ cancer of the cervix, stomach, or colon, or other solid tumours curatively treated with no evidence of disease for > 5 years. 8)Positive for HBs-Ag, HCV-Ab, and/or HIV-Ab. 9)Drug hypersensitivity syndrome. 10) Patient is not able and willing to complete the consensus. 11)Other serious intercurrent illness or medical condition judged by the local investigator to preclude safe administration of the planned protocol treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method response rate (CR and PR)
- Secondary Outcome Measures
Name Time Method toxicity 2 year progression-free survival 2 year overall survival time to response quality of life hospitalization rates economic analysis