Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients
Public ClinicalTrials.gov record NCT03876769. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03876769
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 121 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Year 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
- Jun 24, 2019 (Actual)
- Primary completion
- Oct 19, 2027 (Estimated)
- Completion
- Oct 19, 2027 (Estimated)
- Last update posted
- Aug 19, 2026
2019 – 2027
United States locations
- U.S. sites
- 30
- U.S. states
- 20
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children s Hospital of Alabama | Birmingham | Alabama | 35233 | — |
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | — |
| City of Hope National Medical | Duarte | California | 91010 | — |
| Childrens Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Mattel Childrens Hospital UCLA | Los Angeles | California | 90095 | — |
| Childrens Hospital of Orange County | Orange | California | 92868-3874 | — |
| Rady Children s Hospital | San Diego | California | 92123 | — |
| UCSF Medical Center | San Francisco | California | 94143 | — |
| Stanford University Medical Center | Stanford | California | 94304 | — |
| Childrens Hospital Colorado | Aurora | Colorado | 80045 | — |
| Childrens National Hospital | Washington D.C. | District of Columbia | 20010 | — |
| Johns Hopkins All Childrens | St. Petersburg | Florida | 33701 | — |
| Childrens Healthcare of Atlanta | Atlanta | Georgia | 30342 | — |
| Indiana University | Indianapolis | Indiana | 46202-5225 | — |
| Johns Hopkins Oncology Center | Baltimore | Maryland | 21231 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Children s Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Hackensack Uni Medical Center | Hackensack | New Jersey | 07601 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Memorial Sloan Kettering Cancer Ctr | New York | New York | 10065 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Cinn Children Hosp Medical Center | Cincinnati | Ohio | 45229-3039 | — |
| Oregon Health and Science University | Portland | Oregon | 97239-3098 | — |
| The Childrens Hosp of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Univ of Texas Southwest Med Center | Dallas | Texas | 75390-9034 | — |
| Texas Childrens Cancer and Hematology Center | Houston | Texas | 77030 | — |
| Methodist Childrens Hospital | San Antonio | Texas | 78229 | — |
| University of Utah Clinical Trials Office | Salt Lake City | Utah | 84108 | — |
| Childrens Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03876769, 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 Aug 19, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03876769 live on ClinicalTrials.gov.