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Long-term Safety of UCART19 for Leukemia

Phase 1

Waitlist Available

Led By Reuben Benjamin, MD, PhD

Research Sponsored by Institut de Recherches Internationales Servier

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 year

Awards & highlights

Study Summary

This trial will test if a new leukemia treatment is safe and effective.

Who is the study for?

This trial is for patients with advanced lymphoid leukemia who have previously received UCART19, either through a past study or compassionate use. Participants must agree to effective birth control for 12 months post-treatment and provide written consent.Check my eligibility

What is being tested?

The study focuses on the long-term safety and effectiveness of UCART19 in individuals with advanced lymphoid leukemia. It's a follow-up evaluation for those who've already been treated with this intervention.See study design

What are the potential side effects?

Since this is a follow-up study, specific side effects are not listed; however, it will assess any long-term safety concerns arising from previous UCART19 treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Long-term safety of UCART19 with or without alemtuzumab

Secondary outcome measures

Assessment of long-term anti tumor activity of UCART19

Assessment of overall survival

Proportion of patients who underwent allogeneic HSCT (Hematopoietic Stem Cell Transplantation) for patients treated with UCART19

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: UCART19 follow-upExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Institut de Recherches Internationales ServierLead Sponsor

86 Previous Clinical Trials

67,108 Total Patients Enrolled

ADIR, a Servier Group companyIndustry Sponsor

32 Previous Clinical Trials

4,388 Total Patients Enrolled

Reuben Benjamin, MD, PhDPrincipal InvestigatorKing's College Hospital NHS Trust

1 Previous Clinical Trials

25 Total Patients Enrolled

Media Library

UCART19 follow-up Clinical Trial Eligibility Overview. Trial Name: NCT02735083 — Phase 1

Acute Lymphoblastic Leukemia Research Study Groups: UCART19 follow-up

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many venues are data being collected for this investigation?

"This trial is available at 7 distinct medical centres, such as Children's Hospital Los Angeles in LA, University of Texas MD Anderson Cancer Center in Houston, and the esteemed Children's Hospital of Philadelphia. Additionally, other locations are also accommodating this study."

Answered by AI

Has the Food and Drug Administration granted authorization for UCART19 post-treatment care?

"Due to its early phase 1 status, UCART19 follow-up was assigned a score of 1 for safety as there is insufficient data regarding efficacy and risk."

Answered by AI

Is there still open enrollment for participants in this experiment?

"The data on clinicialtrials.gov reveals that this trial is not currently enrolling patients - the study was initially posted in November 2016 and last amended in April 2022. However, there are a multitude of other trials now recruiting participants at this moment with 1454 studies to choose from."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Long-term Safety of Patients With Advanced Lymphoid Leukemia Who Have Been Previously Administered With UCART19

2021. "A Study to Evaluate the Long-term Safety of Patients With Advanced Lymphoid Leukemia Who Have Been Previously Administered With UCART19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02735083.