Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03876769 · ClinicalTrials.gov registry record · Phase 2
Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients
A Phase 2 study of B-cell Acute Lymphoblastic Leukemia, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 121
- Enrollment target
- 20
- Study locations
NCT03876769 is a Phase 2 study of B-cell Acute Lymphoblastic Leukemia that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 121 participants, above the 83-participant average among 21 other B-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target (46% higher). The trial reports 20 study locations across 13 states.
The verdict
NCT03876769, a Phase 2 study of B-cell Acute Lymphoblastic Leukemia, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 121 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL CTL019
Study Locations (20)
California
- City of Hope National Medical - Duarte
- Childrens Hospital Los Angeles - Los Angeles
- Mattel Childrens Hospital UCLA - Los Angeles
- Childrens Hospital of Orange County - Orange
- Rady Children s Hospital - San Diego
- UCSF Medical Center - San Francisco
- Stanford University Medical Center - Stanford
New York
- Roswell Park Cancer Institute - Buffalo
- Memorial Sloan Kettering Cancer Ctr - New York
Alabama
- Children s Hospital of Alabama - Birmingham
Arizona
- Phoenix Childrens Hospital - Phoenix
Colorado
- Childrens Hospital Colorado - Aurora
District of Columbia
- Childrens National Hospital - Washington D.C.
Florida
- Johns Hopkins All Childrens - St. Petersburg
Georgia
- Childrens Healthcare of Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2019-06-24 |
| Est. Completion | 2027-10-19 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03876769
The ClinicalTrials.gov registry entry for NCT03876769 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 121 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 83-participant average among 21 other B-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target (46% higher). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with B-cell Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which CTL019 is the first listed.
NCT03876769 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, New York, Alabama.
Frequently Asked Questions
What is clinical trial NCT03876769 about?
NCT03876769 is a clinical study titled "Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients". 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, p...
What is the current status of trial NCT03876769?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 121 participants. The study started on 2019-06-24. Estimated completion is 2027-10-19.
What conditions does trial NCT03876769 study?
This clinical trial studies the following conditions: B-cell Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT03876769?
The interventions under investigation include: CTL019 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03876769?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03876769 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for B-cell Acute Lymphoblastic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Blinatumomab After TCR Alpha Beta/CD19 Depleted HCT
RECRUITING · Phase 2
-
Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL
RECRUITING · Phase 2
-
The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents, and Young Adults With B-ALL
RECRUITING · Phase 2
-
A Phase 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
RECRUITING · Phase 2
-
A Second Infusion (Early Reinfusion) of Tisagenlecleucel in Children and Young Adults With B-Cell Acute Lymphoblastic Leukemia(B-ALL)
ACTIVE NOT RECRUITING · Phase 2
-
Evaluating the Safety and Efficacy of DuoCAR20.19.22-D95 in Adult Patients With Relapsed or Refractory B-cell Malignancies
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.