relapsed/refractory peripheral T-cell non-Hodgkin'
Conditions
Interventions
Reduced-intensity conditioning followed by allogeneic stem cell transplantation
Sponsors
West Japan Hematology Oncology Group/ Hematological Malignancy Therapy Study Group/ Japan Study Group for Cell Therapy and Transplantation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: PTCL (ALK negative anaplastic large cell lymphoma, Angioimmunoblastic T-cell lymphoma, Peripheral T-cell lymphoma, not other specified) Patients with diseases described as follows. SD/PD after first-line chemotherapy or 1st/2nd relapsed patients whose disease is controlled by salvage chemotherapy to CR or PR. PR/SD after second-line chemotherapy in patients whose response after first-line chemotherapy were PR. Any of the following is required. 1) Between 16 and 65 years old 2) Performance status(ECOG) 0-2 3) First allogeneic stem cell transplantation 4) Any of the following donors is available.1. Serologically HLA- matched or -one antigen mismatched-related donor 2. HLA-matched or one allele of HLA-DRB1mismatched-unrelated donor 3. Cord blood unit serologically matched at least 4 of 6 HLA antigens(A,B,DR) and with cryopreserved total nucleated cell dose of more than 2x10E7/kg 5) Written informed consent to participate the trial
Exclusion criteria
Exclusion criteria: Any of the following. A history of autologous transplantation just before enrolment, Positive for HLA antibody (in case of cord blood transplantation), SaO2 bellow 94% in room air, T.Bil over 2.0 mg/dL, Serum creatinine over 2.0 mg/dL, AST or ALT over 2.5xULN, Uncontrolled diabetes, Uncontrolled hypertension, History of severe cardiac disease, Left ventricular ejection fraction smaller than 50%, Patients with other malignant comorbidity, Uncontrolled active infection, Positive for TPHA or HTLV-1 antibody or HIV antibody or HBs antigen, Uncontrolled psychiatric disease, Allergic history to drugs used in the present conditioning regimen or GVHD prophylaxis regimen, Pregnant or during breast feeding, Cases that physicians judged as inappropriate,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival at 1 year after transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Anti-lymphoma effect at day 100 after transplantation, treatment-related toxicity and mortality at day 100 after transplantation, engraftment at day 60 after transplantation, time to hematopoietic recovery, incidence and severity of acute GVHD | — |
Countries
Japan
Contacts
Public ContactYoshinobu Maeda, M.D., Ph.D
Okayama University Hospital Department of Hematology and Oncology
Outcome results
None listed