Allogeneic Stem Cell Transplantation in Relapsed/Refractory T-, NK/T-cell Lymphomas
Relapsed and refractory T-cell lymphomas have been reported to have dismal outcomes. The role of allogeneic stem cell transplantation have been demonstrated in these patients. This clinical trial is studying the efficacy and safety of busulfan plus fludarabine as conditioning therapy followed by allogeneic stem cell tr
| Condition(s) | T-cell Non-Hodgkin Lymphoma, Lymphoma, Extranodal NK-T-Cell |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | Relapsed and refractory T-cell lymphomas have been reported to have dismal outcomes. The role of allogeneic stem cell transplantation have been demonstrated in these patients. This clinical trial is studying the efficacy and safety of busulfan plus fludarabine as conditioning therapy followed by allogeneic stem cell transplantation (Allo-SCT) in T- and NK/T-cell lymphoma patients who have relapsed or are refractory to previous chemotherapies including autologous transplantation. |
| Who can participate | Inclusion Criteria: 1. Age 19 - 65 2. Histologically confirmed T or NK cell lymphomas : * anaplastic large cell lymphoma * angioimmunoblastic T-cell lymphoma, * peripheral T-cell lymphoma, NOS * NK/T-cell lymphoma 3. Relapsed after or refractory to one or more of previous chemotherapy including frontline autologous HSCT. 4. At least one measured lesion using conventional CT or PET CT at the time of relapse after or refractory to one or more of previous chemotherapy and before salvage chemotherapy 5. Complete or Partial response after short cycles of salvage chemotherapy 6. Patients who have HLA full-match (8/8 in HLA-A, B, C, DR by DNA high-resolution technique) or one-locus mismatch (7/8) sibling, or unrelated bone marrow or peripheral blood or cord blood stem cell donors 7. ECOG performa |
| Ages | 19 Years to 65 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Keimyung University Dongsan Medical Center |
| Locations | Busan, South Korea; Daegu, South Korea |
| Start date | 2016-12 |
| NCT ID | NCT02859402 |
| Official listing | https://clinicaltrials.gov/study/NCT02859402 |