# PTLD-1

Source: https://onco.cc/trials/ptld-1/  
OnCo record `ptld-1` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-22
- Also known as: PTLD-1/3; PTLD-1 RSST; PTLD-1 risk-stratified sequential treatment
- Tags: soc-trials
- Registry id: NCT00590447
- Phase: 2
- Setting: 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)
- Sponsor: Charite University, Berlin, Germany
- Enrolled: 152
- Result: Overall response 88 percent and complete remission 70 percent with risk-stratified sequential treatment; three-year response duration 82 percent; median overall survival 6.6 years; treatment-related mortality 8 percent.
- Outcomes: Overall response rate (complete or partial response after risk-stratified sequential treatment): Rituximab induction then rituximab or R-CHOP consolidation by response 88%; Complete response rate: Rituximab induction then rituximab or R-CHOP consolidation by response 70%; Response duration at 3 years: Rituximab induction then rituximab or R-CHOP consolidation by response 82%; Overall survival: Rituximab induction then rituximab or R-CHOP consolidation by response 6.6 years; Treatment-related mortality: Rituximab induction then rituximab or R-CHOP consolidation by response 8%

## Sources

- ClinicalTrials.gov NCT00590447: https://clinicaltrials.gov/study/NCT00590447

## Connected records

- cancers: [Non-Hodgkin lymphoma (all types)](https://onco.cc/cancers/non-hodgkin-lymphoma/), [Post-transplant lymphoproliferative disorder (PTLD)](https://onco.cc/cancers/post-transplant-lymphoproliferative-disorder/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- drugs: [Cyclophosphamide](https://onco.cc/drugs/cyclophosphamide/), [Doxorubicin](https://onco.cc/drugs/doxorubicin/), [Filgrastim (G-CSF)](https://onco.cc/drugs/filgrastim/), [Prednisone](https://onco.cc/drugs/prednisone/), [Rituximab](https://onco.cc/drugs/rituximab/), [Vincristine](https://onco.cc/drugs/vincristine/)
- institutions: [Charité Universitätsmedizin Berlin](https://onco.cc/institutions/charite/)
- key papers: [PTLD-1: response to rituximab induction as a predictive marker allowing stratification into rituximab or R-CHOP consolidation in B-cell post-transplant lymphoproliferative disorder](https://onco.cc/key-papers/paper-ptld-1-risk-stratified-sequential-treatment-trappe-jco-2017/)

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