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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: Active Phase 2 study of B-cell Acute Lymphoblastic Leukemia, sponsored by Novartis Pharmaceuticals.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

DFS is defined as the time from the date of tisagenlecleucel infusion to the date of the first documented morphological relapse, occurrence of secondary malignancy or death due to any cause. Participants are not censored at the start of subsequent anticancer therapy or SCT while in remission.

Conditions Studied

B-cell Acute Lymphoblastic Leukemia

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

FieldValue
Enrollment Target 121 participants
Start Date 2019-06-24
Est. Completion 2027-10-19
Phase Phase 2
Novartis Pharmaceuticals

1,375 total trials

What the registry record for NCT03876769 still lists

NCT03876769 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, above the 83-participant average among 21 other B-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target (46% higher).

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 names 20 study sites across 13 states, led by 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.

Where NCT03876769's enrollment target sits among peer trials

121 6th of 21 higher than 16 of 21 other B-cell Acute Lymphoblastic Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other B-cell Acute Lymphoblastic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03876769, the US trial registry maintained by the National Library of Medicine. NCT03876769 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.