# SYMPATICO

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

## TL;DR

SYMPATICO showed that adding the BCL2 blocker venetoclax to ibrutinib for people whose mantle cell lymphoma had returned kept the disease under control for about ten months longer than ibrutinib alone, and the combination also produced complete responses in most untreated patients with the hard-to-treat TP53 mutation.

## Summary

SYMPATICO was a phase 3 trial by Pharmacyclics and Janssen in 366 patients. After a safety run-in that monitored tumour lysis syndrome, patients with relapsed or refractory mantle cell lymphoma were randomised double-blind to ibrutinib 560 mg daily with venetoclax (ramped to 400 mg) for two years or with placebo; a separate open-label arm gave the combination to treatment-naive patients with TP53-mutated disease. The primary endpoint of the randomised phase was investigator-assessed progression-free survival.

In the registry results, at a median time on study of 61.3 months, median progression-free survival was 31.9 months with ibrutinib-venetoclax against 22.1 months with ibrutinib-placebo (hazard ratio 0.629), and the complete response rate in the treatment-naive TP53-mutated arm was 69.2 percent. One tumour lysis syndrome event occurred in the run-in among patients at increased risk. The corpus's mantle cell lymphoma page lists a BTK inhibitor with or without venetoclax on this trial.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-22
- Also known as: PCYC-1143-CA
- Tags: soc-trials
- Registry id: NCT03112174
- Phase: 3
- Setting: Relapsed or refractory mantle cell lymphoma after one to five prior lines: ibrutinib with venetoclax or with placebo (double-blind), after a safety run-in for tumour lysis syndrome, plus an open-label treatment-naive arm of the combination in patients with TP53 mutation
- Sponsor: Pharmacyclics LLC.
- Enrolled: 366
- Result: Median progression-free survival 31.9 months with ibrutinib plus venetoclax against 22.1 months with ibrutinib plus placebo (hazard ratio 0.629, p 0.0024); complete response 69.2 percent in treatment-naive TP53-mutated disease.
- Outcomes: Progression-free survival, randomised phase (registry results): Ibrutinib + venetoclax 31.9 months vs Ibrutinib + placebo 22.1 months, HR 0.629; Complete response rate, treatment-naive TP53-mutated arm (registry results): Ibrutinib + venetoclax, open label 69.2%; Tumour lysis syndrome events in the safety run-in (registry results): Increased tumour lysis risk at baseline 1 participants vs Low tumour lysis risk at baseline 0 participants

## Sources

- ClinicalTrials.gov NCT03112174: https://clinicaltrials.gov/study/NCT03112174
- ClinicalTrials.gov results: https://clinicaltrials.gov/study/NCT03112174?tab=results

## Connected records

- cancers: [Mantle cell lymphoma](https://onco.cc/cancers/mantle-cell-lymphoma/), [Non-Hodgkin lymphoma (all types)](https://onco.cc/cancers/non-hodgkin-lymphoma/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- drugs: [Ibrutinib](https://onco.cc/drugs/ibrutinib/), [Venetoclax](https://onco.cc/drugs/venetoclax/)
- companies: [AbbVie (incl. ImmunoGen, Capstan)](https://onco.cc/companies/abbvie/), [Johnson & Johnson](https://onco.cc/companies/johnson-johnson/)

---
JSON: https://onco.cc/api/v1/entities/sympatico.json