Diffuse large B-cell lymphoma
Conditions
Interventions
Patients who have a positive PET scan after 2 cycles of R-CHOP will receive total 6 cycles of standard R-CHOP followed by HDC/ASCT.
Patients who have a negative PET scan after 2 cycles of R-CHOP will
Sponsors
Japan Study Group for Cell Therapy and Transplantation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Newly diagnosed NHL by tissue biopsy; DLBCL, listed under mature B-cell neoplasms according to the WHO classification (diffuse large B-cell lymphoma/NOS, primary mediastinal large B-cell lymphoma, excluding intravascular large B-cell lymphoma). 2.Histologically proven CD20 positive DLBCL. 3.Patients with measurable disease by CT scan. 4.Age: 15-65. 5.Ann Arbor stage: 2-4. 6.Performance status (ECOG): 0-3. 7.Age-adjusted International Prognostic Index (aaIPI): High or High-intermediate. 8.Adequate hematological, hepatic, renal, cardiac, or pulmonary function (Neutrophil count >=1000/mm3, Platelet count >=7.5X104/mm3, AST<=3 X upper limit of normal, ALT<=3 X upper limit of normal, T. Bil<=2.0mg/dL, Cr<=2.0mg/dL, EF>=50%, PaO2>=60 mmHg or SaO2>=90%). 9.Patients without severe complications. 10.The patient must sign the consent form prior to registration. If the patient is under age, both the guardian and the patient must sign the consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with a history of prior or concurrent malignancies. 2.Patients who are on any medication for diabetes. 3.Patients who have severe complications such as active systematic infection, heart failure, respiratory failure, pulmonary disease, hepatic failure, liver cirrhosis, acute or chronic hepatitis, renal failure, active tuberculosis. 4.Patients with a history of angina or cardiac infarction. Patients with cardiomyopathy. Patients taking anti-arrhythmic drugs. 5.Patients with a history of drug anaphylaxis. 6.Patients with severe mental illness. 7.Patients with a history of lymphoma, leukemia, or MDS. 8.Patients with a history of chemotherapy, cytokine therapy, or antibody therapy for present DLBCL. 9.Patients with primary central nervous system lymphoma or with central nervous system involvement of DLBCL 10.Pregnancy or lactation. 11.Known hepatitis B or C virus infection 12.Known HIV or HTLV-1 infection 13.Patients with any medical condition that in the opinion of the investigator would compromise treatment delivery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival at 2 years of patients with a persistently positive PET scan after 2 cycles of R-CHOP | — |
Countries
Japan
Outcome results
None listed