UCART19 follow-up for Acute Lymphoblastic Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Acute Lymphoblastic LeukemiaUCART19 follow-up - Biological
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Acute Lymphoblastic Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Up to 15 Year

Year 15
Proportion of patients with detectable UCART19 levels in blood
Year 15
Assessment of long-term anti tumor activity of UCART19
Year 15
Assessment of overall survival
Proportion of patients who underwent allogeneic HSCT (Hematopoietic Stem Cell Transplantation) for patients treated with UCART19
Proportion of patients with detectable UCART19 levels in bone marrow
Time to transplant for patients treated with UCART19
Up to 15 Year
Long-term safety of UCART19 with or without alemtuzumab

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

UCART19 follow-up
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: UCART19 follow-up · No Placebo Group · Phase 1

UCART19 follow-up
Biological
Experimental Group · 1 Intervention: UCART19 follow-up · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 15 year

Who is running the clinical trial?

Institut de Recherches Internationales ServierLead Sponsor
77 Previous Clinical Trials
69,025 Total Patients Enrolled
ADIR, a Servier Group companyIndustry Sponsor
32 Previous Clinical Trials
4,980 Total Patients Enrolled
Reuben Benjamin, MD, PhDPrincipal InvestigatorKing's College Hospital NHS Trust
1 Previous Clinical Trials
25 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have obtained written informed consent prior to any study-specific procedure (patient or parent(s) or legal representative).
You are female and/or male and have not used an effective method of birth control for at least 12 months.