A Second Infusion (Early Reinfusion) of Tisagenlecleucel in Children and Young Adults With B-Cell Acute Lymphoblastic Leukemia(B-ALL) (NCT05460533)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Children's Hospital of Los Angeles (Data Collection Only) — Los Angeles, California
Age range: 1 Day to 25 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (6 Sites)
- Children's Hospital of Los Angeles (Data Collection Only) — Los Angeles, California
- Stanford University (Data Collection Only) — Stanford, California
- Children's Hospital Colorado (Data Collection Only) — Aurora, Colorado
- Johns Hopkins University (Data Collection Only) — Baltimore, Maryland
- Memorial Sloan Kettering Cancer Center — New York, New York
- Cincinnati Children's Hospital Medical Center (Data Collection Only) — Cincinnati, Ohio
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in B-cell Acute Lymphoblastic Leukemia
- A Phase 1b/2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Combination With Low Intensity Chemotherapy in Older Patients With Newly Diagnosed B-Cell Acute Lymphoblastic Leukemia — Houston, Texas
- Venetoclax Plus Inotuzumab for B-ALL — Boston, Massachusetts
- Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients — Birmingham, Alabama
- Study Of KITE-753 in R/R B-Cell ALL — Houston, Texas
- A Study of Inotuzumab and Blinatumomab in People With B-cell Acute Lymphoblastic Leukemia — New York, New York
Explore by condition: All B-cell Acute Lymphoblastic Leukemia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.