Diffuse large B-cell lymphoma
Conditions
Interventions
multi-center, single arm open label Phase II clinical study
Sponsors
National Hospital Organization Kyushu Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients older than 65 years of age. 2) Tissue diagnosis for diffuse large B-cell lymphoma (DLBCL, ccording to the World Health Organization), documented at initial diagnosis or at relapse. Biopsy proof at relapse is desirable but not mandatory.More than 3 cycles of rituximab in combination with chemotherapy for prior DLBCL. 3) CD20 positive either at diagnosis or relapse. 4) Measurable disease is defined. 5) ECOG performance status 0, 1 or 2. 6) Laboratory Requirements: Absolute granulocytes > 1.0 x 10^9/L,Platelets > 50 x 10^9/L, LV ejection fraction of > 50 % Pulmonary sufficiency (PaO2 >60mmHg or sPO2 >93% on room air), AST or ALT < 5 x ULN, Creatinine clearance > 30 ml/min 7) Patient is able and willing to complete the quality of life questionnaires in validated translations. Inability (illiteracy, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate (CR and PR) | — |
Secondary
| Measure | Time frame |
|---|---|
| toxicity 2 year progression-free survival 2 year overall survival time to response quality of life hospitalization rates economic analysis | — |
Countries
Japan
Contacts
Public ContactSATOSHI YAMASAKI
National Hospital Organization Kyushu Medical Center Department of Hematology and Clinical Research Institute
Outcome results
None listed