Peripheral T-cell lymphoma with complete metabolic response after induction chemotherapy
Conditions
Interventions
Induction chemotherapy after primary registration
CD30 positive: BV+CHP (Brentuximab Vedotin 1.8 mg/kg day1, Cyclophosphamide 750 mg/m2 day1, Doxorubicin 50 mg/m2 day1, Prednisolone 100 mg/body day1
Sponsors
ISHITSUKA Kenji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Primary registration criteria (1) Pathologically proven peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), follicular T-cell lymphoma (FTCL), nodal peripheral T-cell lymphoma with T follicular helper cell phenotype (nPTCL with TFH phenotype), or anaplastic large cell lymphoma ALK-negative type (ALK-negative ALCL). (2) The presence or absence of the CD30 antigen in tumor cells has been confirmed by immunohistochemical staining of biopsy or surgical resection specimens. (3) Aged 18 to 65 years old at primary registration (4) ECOG performance status of 0 to 2. (5) Presence of clear FDG uptake in lesions on FDG-PET/CT within 56 days prior to primary registration. (6) No prior treatment of chemotherapy, radiotherapy, or antibody therapy for peripheral T-cell lymphoma. (7) No central nervous system involvement on clinical diagnosis. (8) Sufficient organ function (i) Neutrophil >= 1,000/mm3 (>= 500/mm3 in patients with bone marrow invasion of lymphoma) (ii) Hb >= 8.0 g/dL (iii) Platelet >= 75,000/mm3 (>= 50,000/mm3 in patients with bone marrow invasion of lymphoma) (iv) T.Bil = 30mL/min (viii) SpO2 >= 93% (room air). (9) Sufficient cardiac function. (i) No ischemic changes, atrial fibrillation, or ventricular arrhythmias requiring treatment on the latest ECG. (ii) LVEF >= 50% on echocardiography. (10) Written informed consent. Secondary registration criteria (1) Primary registration of this trial. (2) Following (i) or (ii) is fulfilled. (i) Completion of 6 courses of CHOP or BV+CHP and complete metabolic response on FDG-PET/CT. (ii) Completion of 4 or 5 courses of CHOP or BV+CHP due to difficulty in continuation arising from adverse events and complete metabolic response on FDG-PET/CT. (3) No grade 2 or higher non-hematologic toxicity except for grade 2 or 3 peripheral sensory neuropathy and grade 2 peripheral motor neuropathy. (4) Sufficient cardiac function (i) No ischemic changes, atrial fibrillation, or ventricular arrhythmias requiring treatment on the latest ECG. (ii) LVEF >= 50% on echocardiography. (5) ECOG performance status of 0 to 2. (6) Sufficient organ function (i) Neutrophil >= 1,000/mm3 (ii) Hb >= 8.0 g/dL (iii) Platelet >= 75,000/mm3 (iv) T.Bil = 30mL/min (viii) SpO2 >= 93% (room air). (7) Within 22 to 56 days from the start date of the final course of CHOP or BV+CHP.
Exclusion criteria
Exclusion criteria: (1) Synchronous or metachronous (within 5 years) malignancies. (2) Infectious disease requiring systemic treatment. (3) Female during pregnancy, within 28 days of postparturition, or during lactation. Males with partners planning conception shortly. (4) Severe psychological disorder difficult to participate in this clinical study. (5) Receiving continuous systemic corticosteroid or immunosuppressant treatment. (6) Uncontrollable diabetes mellitus. (7) Uncontrollable hypertension. (8) Unstable angina pectoris, or history of myocardial infarction within 6 months. (9) Uncontrollable valvular heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy. (10) Positive HBs antigen or HCV antibody. (11) Positive HIV antibody. (12) HTLV-1 antibody positive (screening test positive and LIA test positive). (13) Interstitial pneumonia, pulmonary fibrosis or severe pulmonary emphysema based on chest CT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, complete metabolic response rate after induction chemotherapy, adverse events, serious adverse events. | — |
Contacts
Public ContactKenji ISHITSUKA
Kagoshima University Hospital
Outcome results
None listed