# BELINDA

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

## TL;DR

The one second-line CAR-T trial that failed, a reminder that manufacturing time and trial design can erase a real effect.

## Summary

BELINDA, trial NCT03570892 sponsored by Novartis and reported in 2021, was the one second-line CAR-T trial that failed, a reminder that manufacturing time and trial design can erase a real effect. It randomised 322 patients with early-relapsed or refractory aggressive B-cell lymphoma to tisagenlecleucel or salvage chemotherapy and transplant and found no difference in event-free survival, which the record attributes to a long vein-to-vein time of 52 days, permitted crossover chemotherapy before CAR-T and a strict week-twelve event definition. OnCo links it to lymphoma, CAR-T, the pairing of CAR-T before transplant at early relapse and the JULIET, TRANSFORM and ZUMA-7 papers, and it is contradicted by ZUMA-7 and TRANSFORM, which used faster products and no crossover. Whether tisagenlecleucel would have matched them under the same design is the question the trial cannot answer.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-07
- Tags: lesson:trial-design
- Registry id: NCT03570892
- Phase: 3
- Setting: Early-relapsed/refractory aggressive B-cell lymphoma: tisagenlecleucel vs salvage + transplant
- Sponsor: Novartis
- Enrolled: 330
- Result: EFS HR 1.07 (negative).
- Outcomes: Event-free survival (median): Tisagenlecleucel 3 months vs Standard care 3 months, HR 1.07
- Replication: Contradicted by ZUMA-7 and TRANSFORM, which used faster products and no crossover before CAR-T.

## Sources

- ClinicalTrials.gov NCT03570892: https://clinicaltrials.gov/study/NCT03570892

## Connected records

- roadmaps: [Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting](https://onco.cc/roadmaps/lymphoma-roadmap/)
- trials: [JULIET](https://onco.cc/trials/juliet/), [TRANSCEND NHL 001](https://onco.cc/trials/transcend-nhl-001/), [TRANSFORM](https://onco.cc/trials/transform/), [ZUMA-7](https://onco.cc/trials/zuma-7/)
- ideas: [Report the time from apheresis to infusion as a trial endpoint, not a logistics footnote](https://onco.cc/ideas/lymphoma-ev-manufacturing-time-as-a-trial-endpoint/)
- cancers: [Diffuse large B-cell lymphoma](https://onco.cc/cancers/dlbcl/), [Non-Hodgkin lymphoma (all types)](https://onco.cc/cancers/non-hodgkin-lymphoma/)
- technologies: [CAR-T cell therapy](https://onco.cc/technologies/car-t/)
- companies: [Novartis](https://onco.cc/companies/novartis/)
- key papers: [JULIET: tisagenlecleucel for adults with relapsed or refractory diffuse large B-cell lymphoma](https://onco.cc/key-papers/paper-juliet-tisagenlecleucel-dlbcl-nejm-2019/), [Second-line tisagenlecleucel or standard care in aggressive B-cell lymphoma](https://onco.cc/key-papers/paper-belinda-tisagenlecleucel-second-line-nejm-2022/), [TRANSFORM: liso-cel CAR-T versus salvage chemotherapy and transplant in early-relapsing large B-cell lymphoma](https://onco.cc/key-papers/paper-transform-liso-cel-lancet-2022/), [ZUMA-7: axi-cel CAR-T instead of salvage chemotherapy and transplant for large B-cell lymphoma that relapses early](https://onco.cc/key-papers/paper-zuma-7-axi-cel-second-line-nejm-2022/)
- pairings: [Early relapse: CAR-T before transplant](https://onco.cc/pairings/car-t-before-transplant-lbcl/)
- terms: [Lymphoma treatments that did not work: the negative trials worth knowing](https://onco.cc/terms/lymphoma-tx-failed-and-negative/), [The CAR-T pathway in lymphoma: referral, apheresis, bridging and the waiting](https://onco.cc/terms/lymphoma-tx-car-t-pathway/), [Transplant or CAR-T at second line in diffuse large B-cell lymphoma](https://onco.cc/terms/lymphoma-decision-transplant-or-car-t/), [Trial protocol and statistical analysis plan](https://onco.cc/terms/trial-protocol/), [Why trials fail: underpowered, wrong endpoint, control arm drift, subgroup fishing, crossover](https://onco.cc/terms/trial-failure-modes/)

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