CompletedPhase 2

Phase II Open Label Trial to Determine Safety & Efficacy of Tisagenlecleucel in Pediatric Non-Hodgkin Lymphoma Patients

United States34 participantsStarted 2019-02-15

Plain-language summary

The purpose of the study was to assess the efficacy and safety of tisagenlecleucel in pediatric, adolescent and young adult patients with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL) including Burkitt Lymphoma and Burkitt Leukemia. For pediatric patients who have r/r B-NHL including Burkitt Lymphoma and Burkitt Leukemia, survival rates are dismal, only \~20-50% subjects are alive at 2 years with overall response rate (ORR) of 20-30% after conventional salvage chemotherapy.

Who can participate

Age range25 Years

SexALL

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Inclusion criteria

✓. Absolute neutrophil count (ANC) \>1000/mm3
✓. Platelets ≥50000//mm3
✓. Hemoglobin ≥8.0 g/dl
✓. a serum creatinine (sCR) based on gender/age as follows: Maximum Serum Creatinine (mg/dL) Age Male Female
✓. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5 times the upper limit of normal (ULN) for age
✓. Total bilirubin \<2 mg/dL (for Gilbert's Syndrome patients total bilirubin \<4 mg/dL)
✓. Adequate pulmonary function

What they're measuring

Overall Response Rate (ORR) as Determined by Local Investigator

Timeframe: 6 months post-tisagenlecleucel infusion

Trial details

NCT IDNCT03610724

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-07-27

Results submitted2023-10-25

View on ClinicalTrials.gov More Non-Hodgkin Lymphoma trials