Find Clinical Trials
Study of UCART19 in Pediatric Patients With Relapsed/Refractory B Acute Lymphoblastic Leukemia (PALL)
Servier Protocol Code:
UCART19_02 (CL1-68587-001)
Sponsor:
Institut de Recherches Internationales Servier
Clinicaltrials.gov Identifier:
NCT02808442
EudraCT Number:
2015-004293-15
Other protocol name:
UCART19_02
Find a recruiting site
How to participate in this study
If you think you are eligible for this study (see
below), you can identify the location closest to you and contact them directly. If you can’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
eligibility criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Name:
Institut de Recherches Internationales Servier, Département des études cliniques
Phone number:
+33 1 55 72 60 00
The study has 6 locations
Study description
This study aims to evaluate the safety and feasibility of UCART19 to induce molecular remission in pediatric patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL).
Official title: A Phase 1, Open Label, Non-comparative Study to Evaluate the Safety and the Ability of UCART19 to Induce Molecular Remission in Paediatric Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukaemia
Results
English (USA)Conditions
Refractory B-cell Acute Lymphoblastic Leukemia
Relapsed B-cell Acute Lymphoblastic Leukemia
Interventions / Treatments
The treatment(s) given to the participants in the study.
- UCART19
Other study id numbers
Other identification numbers the study may be known by.
- UCART19_02 (CL1-68587-001)
Eligibility Criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligible age for the study
(Child)
Sex
Male/FemaleAccepts Healthy Volunteers
No- * Patient with relapsed or refractory CD19-positive B-acute lymphoblastic leukaemia (B-ALL) who have exhausted alternative treatment options.
- * Estimated life expectancy ≥ 12 weeks
- * Lansky (age < 16 years at the time of assent/consent) or Karnofsky (age ≥ 16 years at time of assent/consent) performance status ≥ 50
- * Burkitt leukemia
- * CD19-negative B-cell leukemia
- * Active Central Nervous System (CNS) leukemia
- * Active acute or chronic Graft-versus-Host Disease (GvHD) requiring systemic use therapy within 4 weeks before UCART19 infusion
- * Patients with autoimmune disease requiring systemic immunosuppression therapy that cannot be stopped
- * History of CRS grade 4 related to previous CAR T cell therapy
- * Contraindication to Alemtuzumab administration
How is the study designed?
Allocation
How participants are assigned to different groups. Allocation can be random (randomized) or predetermined (non-randomized). Randomized means that participants are assigned at random to their participant group / arm.
Interventional study model
How treatments are given and tested in a study.
Single Group
A single group study design involves studying one group of participants who all receive the same treatment. Researchers observe the group's results to understand the effects of the treatment.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Intervention / Treatment
The treatment(s) given to the participants in the study.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Experimental:
UCART19
Intervention / Treatment
The treatment(s) given to the participants in the study.
Biological:
UCART19
Keywords
Additional Relevant MeSH Terms Glioma
Burkitt Lymphoma