PTLD-1
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.
Overview
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.
- 88 out of 100 people had their tumour shrink with Rituximab induction then rituximab or R-CHOP consolidation by response.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
- 70 out of 100 people had their tumour shrink with Rituximab induction then rituximab or R-CHOP consolidation by response.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
- 82 out of 100 people reached this endpoint at 3 years with Rituximab induction then rituximab or R-CHOP consolidation by response.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- Rituximab induction then rituximab or R-CHOP consolidation by response: 6.6 years.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- 8 out of 100 people alive with Rituximab induction then rituximab or R-CHOP consolidation by response.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: CD20-positive post-transplant lymphoproliferative disorder after solid organ transplantation, unresponsive to reduction of immunosuppression: four weekly doses of rituximab, then consolidation chosen by response, four further rituximab doses for patients in complete remission and four cycles of R-CHOP for everyone else (risk-stratified sequential treatment). People in a different situation may not see the same effect.
- The trial selected people by a biomarker (CD20); the result should not be assumed for people whose cancer does not have it.
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 |
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