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Active, not recruiting Phase 2 Interventional

A Second Infusion (Early Reinfusion) of Tisagenlecleucel in Children and Young Adults With B-Cell Acute Lymphoblastic Leukemia(B-ALL)

ClinicalTrials.gov ID: NCT05460533

Public ClinicalTrials.gov record NCT05460533. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 9:39 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase II Open Label Multicenter Study of Early REinFusion of Tisagenlecleucel to Promote DUrable B-CEll ApLasia in Pediatric and Young Adult Patients With Relapsed/Refractory CD19-Positive B-Cell Acute Lymphoblastic Leukemia (REFUEL)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The researchers are doing this study to see if early reinfusion of tisagenlecleucel can keep participants in B-CEll ApLasia at 6 months after their first infusion. The researchers will also look at the safety of early reinfusion and how effective it is at treating B-ALL.

Study identification

NCT ID
NCT05460533
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Enrollment
30 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
1 Day to 25 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 12, 2022 (Actual)
Primary completion
Jul 2027 (Estimated)
Completion
Jul 2027 (Estimated)
Last update posted
Feb 4, 2026

2022 – 2027

United States locations

U.S. sites
6
U.S. states
5
U.S. cities
6
Facility City State ZIP Site status
Children's Hospital of Los Angeles (Data Collection Only) Los Angeles California 90027 —
Stanford University (Data Collection Only) Stanford California 94305 —
Children's Hospital Colorado (Data Collection Only) Aurora Colorado 80045 —
Johns Hopkins University (Data Collection Only) Baltimore Maryland 21287 —
Memorial Sloan Kettering Cancer Center New York New York 10065 —
Cincinnati Children's Hospital Medical Center (Data Collection Only) Cincinnati Ohio 45229 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05460533, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 4, 2026 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05460533 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →