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Phase III B in Acute Lymphoblastic Leukemia

NCT03123939 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2021-07-21

Study results available
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Summary

This is a single arm, open-label, multi-center, phase III B study to determine the safety and efficacy of CTL019 in pediatric/young adult patients with r/r B-cell Acute Lymphoblastic Leukemia (ALL).

Conditions

Interventions

BIOLOGICAL

CTL019

CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-24
Primary Completion
2020-10-13
Completion
2020-10-13
FDA Drug
Yes

Countries

  • Austria
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Japan
  • Norway
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03123939 on ClinicalTrials.gov