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PTLD-1 established how to treat lymphoma that arises after an organ transplant: start with the antibody rituximab alone, and use how well the patient responds to decide whether to continue rituximab or move to chemotherapy; seven in ten reached complete remission and patients lived a median of more than six years.
PTLD-1 was an international prospective phase 2 trial coordinated from Charite Berlin in adults with CD20-positive post-transplant lymphoproliferative disorder after solid organ transplantation that had not responded to reduced immunosuppression. The original protocol gave sequential rituximab then CHOP to all; the risk-stratified amendment (PTLD-1/3) gave four weekly rituximab infusions and then, in patients with a complete response, four further rituximab doses, while all others received four cycles of R-CHOP with G-CSF support. The primary endpoint was the overall response rate.
Among 126 patients in the risk-stratified analysis, 111 (88 percent) responded and 88 (70 percent) reached complete remission; the three-year response duration estimate was 82 percent and median overall survival 6.6 years, with grade 3 or 4 infections in 34 percent and treatment-related mortality of 8 percent. Response to rituximab induction remained prognostic despite stratification. The corpus's post-transplant lymphoproliferative disorder page describes rituximab consolidation alone for complete responders and R-CHOP for the rest on this evidence.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
152 enrolled.
95% CI 81 to 93
Source95% CI 61 to 77
Source95% CI 74 to 90
Source95% CI 5 to 14; grade 3 or 4 infections 34 percent
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall response rate (complete or partial response after risk-stratified sequential treatment)primary | Rituximab induction then rituximab or R-CHOP consolidation by response | 126 | 88% | - | - | link |
| Complete response rate | Rituximab induction then rituximab or R-CHOP consolidation by response | 126 | 70% | - | - | link |
| Response duration at 3 years | Rituximab induction then rituximab or R-CHOP consolidation by response | 126 | 82% | - | - | link |
| Overall survival | Rituximab induction then rituximab or R-CHOP consolidation by response | 126 | 6.6 years | - | - | link |
| Treatment-related mortality | Rituximab induction then rituximab or R-CHOP consolidation by response | 126 | 8% | - | - | link |
Shares Prednisone, Vincristine, Rituximab, Doxorubicin and the tag soc-trials.
Shares Prednisone, Vincristine, Doxorubicin, Cyclophosphamide and the tag soc-trials.
Shares Filgrastim (G-CSF), Vincristine, Doxorubicin, Cyclophosphamide and the tag soc-trials.
Shares Prednisone, Vincristine, Rituximab, Doxorubicin and the tag soc-trials.
Shares Prednisone, Vincristine, Doxorubicin, Cyclophosphamide and the tag soc-trials.
Shares Prednisone, Vincristine, Rituximab, Doxorubicin and the tag soc-trials.
Shares Vincristine, Doxorubicin, Cyclophosphamide, Cytotoxic chemotherapy and the tag soc-trials.
Shares Vincristine, Cyclophosphamide, Cytotoxic chemotherapy and the tag soc-trials.