Diffuse large B-cell lymphoma
Conditions
Interventions
R-CHOP High-dose methotrexate Intrathecal methotrexate
Sponsors
Department of Hematology and Oncology, Osaka University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed diffuse large B-cell lymphoma 2. High or high-intermediate IPI risk and stage III or IV 3. Patients aged >=20 years 4. Adequate organ function as follows; #1 Absolute neutrophil count >= 1000/mm3 #2 Platelet count >= 100,000/mm3 #3 Estimated EGFR >= 50 #4 AST and ALT levels <= 3 times the upper limit of the normal range #5 SpO2 >= 95% #6 Normal ECG #7 (If echocardiogram is done) Left ventricular ejection fraction > 50% #8 Karnofsky Performance Status >= 40 5. Patients who have at least one measurable lesion, or evaluable disease if there is no measurable lesion. Measurable lesion can be accurately measured in two dimensions orthogonal with each other by CT scan. Malignant lymph nodes are to be considered pathologically enlarged and measurable, a lymph node must be >=15mm in long axis or >=10mm in short axis when assessed by CT scan. Extranodal lesions must be accurately measured in at least one dimension as >=10mm by CT scan (CT scan slice thickness is no greater than 5mm; when CT scan have slice thickness >5mm, the minimum size should be twice the slice thickness). Evaluable disease is non-measurable lesions but can be confirmed as lymphoma by CT, MRI, PET or endoscopy. 6. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Primary CNS lymphoma (include intraocular lymphoma) or lymphoma with cns involvement on CT and/or MRI, or CSF examination on admission 2. Intravascular lymphoma, primary effusion lymphoma, mediastinal large B-cell lymphoma 3. Primary testicular lymphoma 4. Patients with peripheral bood involvement of lymphoma on admission 5. Prior treatment for lymphoma except lymph node biopsy and local radiation therapy 6. Presence of fluid in the third space (e.g. pleural effusions) 7. Patients with pre-existing renal insufficiency 8. Patients with another active malignancy 9. Patients with serious complications (malignant hypertension, congestive heart failure, coronary insufficiency, a new onset of myocardial infarction within 3 months, uncontrolled hyperglycemia, pulmonary fibrosis, interstitial pneumonia, etc) 10. Severe psychosis 11. Presence of uncontrollable active infection 12. Patients with allergy to drug used for conditioning regimen 13. Positive for HIV antibody, HCV antibody or HTLV-1 antibody 14. HBs antigen positive patients judged unfeasible to participate in this protocol in spite of the administration of antiviral drugs 15. Patients who are pregnant or lactating 16. Without any written consent from patients 17. Inadequate patients to enroll judged by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year CNS relapse rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, Relapse-free survival, 2-year survival rate, Safety | — |
Countries
Japan
Contacts
Public ContactYasuhiro Nagate
Osaka University Graduate School of Medicine Department of Hematology and Oncology
Outcome results
None listed