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RecruitingNot a traditional drug phaseobservationalRules rewrite

Not a traditional drug phase: tisagenlecleucel for Diffuse Large B-cell Lymphoma

This will be a multicenter, national, non-treatment, prospective cohort study

Official registry: https://clinicaltrials.gov/study/NCT05541341 · Novartis Pharmaceuticals · enrollment listed as 200

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 200 people at 5 sites. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

Effectiveness and Safety of Tisagenlecleucel Therapy in Brazilian Patients With B-lymphocyte Malignancies: a 15-year Prospective Registry Study on Three Cohorts.

Interventions: tisagenlecleucel

Primary outcome (registry wording): Overall response rate (ORR)

Who it is for (from inclusion criteria)

  • Ages 0 Years to 100 Years
  • Patients eligible for inclusion in this study must meet the following criteria:
  • Patients who receive tisagenlecleucel infusion in the commercial setting or out-of-specification (OOS) use, AND
  • For ALL participants:
  • Patients of any gender aged 0-17 years (named as pediatric) with relapsed/ refractory B-cell ALL diagnosis that received tisagenlecleucel infusion, OR
  • Patients of any gender, aged 18-25 years (named as adults) - with relapsed/ refractory B-cell ALL diagnosis that received tisagenlecleucel infusion, OR
  • For DBLCL and FL participants:
  • Patients of any gender aged 18 years or older, who have been diagnosed with relapsed/ refractory Diffuse Large B-cell Lymphoma and received tisagenlecleucel infusion

Public study contact (from the registry)

Novartis Pharmaceuticals

+41613241111

novartis.email@novartis.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

5 listed

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FAQ about this NCT record

Is NCT05541341 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05541341?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05541341?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary