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

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Status and phase

Completed
Phase 1

Conditions

Refractory B-cell Acute Lymphoblastic Leukemia
Relapsed B-cell Acute Lymphoblastic Leukemia

Treatments

Biological: UCART19

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02808442
2015-004293-15 (EudraCT Number)
UCART19_02 (CL1-68587-001)

Details and patient eligibility

About

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).

Enrollment

13 patients

Sex

All

Ages

Under 17 years old

Volunteers

No Healthy Volunteers

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 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

UCART19
Experimental group
Treatment:
Biological: UCART19

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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