Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients (NCT03876769)
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
🩺 Plain-English Summary (8th-Grade Level)
This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in de novo HR pediatric and young adult B-ALL patients who received first-line treatment and are EOC MRD positive. The study will have the following sequential phases: screening, pre-treatment, treatment \& follow-up, and survival. After tisagenlecleucel infusion, patient will have assessments performed more frequently in the first month and then at Day 29, then every 3 months for the first year, every 6 months for the second year, then yearly until the end of the study. Efficacy and safety will be assessed at study visits and as clinically indicated throughout the study. The study is expected to end in approximately 8 years after first patient first treatment (FPFT). A post-study long term follow-up safety will continue under a separate protocol per health authority guidelines.
Who can join: Review the eligibility criteria below.
Location: Children s Hospital of Alabama — Birmingham, Alabama
Age range: 1 Year 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 (43 Sites)
Showing the first 25 of 43 sites.
- Children s Hospital of Alabama — Birmingham, Alabama
- Phoenix Childrens Hospital — Phoenix, Arizona
- City of Hope National Medical — Duarte, California
- Childrens Hospital Los Angeles — Los Angeles, California
- Mattel Childrens Hospital UCLA — Los Angeles, California
- Childrens Hospital of Orange County — Orange, California
- Rady Children s Hospital — San Diego, California
- UCSF Medical Center — San Francisco, California
- Stanford University Medical Center — Stanford, California
- Childrens Hospital Colorado — Aurora, Colorado
- Childrens National Hospital — Washington D.C., District of Columbia
- Johns Hopkins All Childrens — St. Petersburg, Florida
- Childrens Healthcare of Atlanta — Atlanta, Georgia
- Indiana University — Indianapolis, Indiana
- Johns Hopkins Oncology Center — Baltimore, Maryland
- Dana Farber Cancer Institute — Boston, Massachusetts
- Children s Mercy Hospital — Kansas City, Missouri
- Hackensack Uni Medical Center — Hackensack, New Jersey
- Roswell Park Cancer Institute — Buffalo, New York
- Columbia University Medical Center — New York, New York
- Memorial Sloan Kettering Cancer Ctr — New York, New York
- Duke University Medical Center — Durham, North Carolina
- Cinn Children Hosp Medical Center — Cincinnati, Ohio
- Oregon Health and Science University — Portland, Oregon
- The Childrens Hosp of Philadelphia — Philadelphia, Pennsylvania
💰 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 Second Infusion (Early Reinfusion) of Tisagenlecleucel in Children and Young Adults With B-Cell Acute Lymphoblastic Leukemia(B-ALL) — Los Angeles, California
- 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 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.