Study of UCART19 in Pediatric Patients With Relapsed/Refractory B Acute Lymphoblastic Leukemia



Status:Active, not recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 17
Updated:11/30/2018
Start Date:June 3, 2016
End Date:April 2020

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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

This study aims at evaluating 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).


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
3
sites
4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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mi
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Los Angeles, CA
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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mi
from
Philadelphia, PA
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Gent,
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