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Trials
Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients

trialsTrialActive

Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients

A phase 2 trial of Tisagenlecleucel in acute lymphoblastic leukaemia, run by Novartis Pharmaceuticals, active and no longer recruiting.

Overview Connected6

Overview

Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients is a phase 2 interventional study registered as NCT03876769 by Novartis Pharmaceuticals, with 121 participants enrolled, started 2019-06-24 and due to reach its primary completion in 2027-10-19. Interventions recorded: CTL019.

Setting

A Phase II Trial of Tisagenlecleucel in First-line High-risk (HR) Pediatric and Young Adult Patients With B-cell Acute Lymphoblastic Leukemia (B-ALL) Who Are Minimal Residual Disease (MRD) Positive at the End of Consolidation (EOC) Therapy

Phase

Phase 2

Sponsor

Novartis Pharmaceuticals

Registry

Started

2019-06-24

Enrolled

121 enrolled

Connected

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cancers

Acute lymphoblastic leukaemia High-risk acute lymphoblastic leukaemia in children (high-risk B-ALL and T-ALL)

technologies

CAR-T cell therapy

drugs

ApprovedCAR-T (CD19)

Tisagenlecleucel · Kymriah

companies

Advanced Accelerator Applications (Novartis)Novartis

Evidence strength30/100 · Emerging

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 2+15
121 enrolled+10
No structured primary endpoint0
Result: active0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-22 · Jude Gomila · Wave 2 corpus-only joins applied · diff · file

Sources & links

ClinicalTrials.gov NCT03876769

Data

JSON ·

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Cancers

Acute lymphoblastic leukaemia
High-risk acute lymphoblastic leukaemia in children (high-risk B-ALL and T-ALL)

Technologies

CAR-T cell therapy

Products

Tisagenlecleucel

Companies

Novartis

Not yet reviewedNeeds expert (clinical) review. Review this page or see the review queue and roster.

Model panel commentary is coming to this page: machine commentary, not clinical review.

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MCP server: npx -y onco-mcp, tools search, get_entity, list_kind, ask, context, compare. This record is get_entity or context with id nct03876769.

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