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Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients

NCT02445248 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2024-04-18

Study results available
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Summary

This is a multi-center, phase II study to determine the efficacy and safety of CTL019 in adult patients with relapsed or refractory DLBCL.

Conditions

  • Diffuse Large B-cell Lymphoma (DLBCL)

Interventions

BIOLOGICAL

Tisagenlecleucel

The target dose of CTL019 transduced cells for adult patients consisted of a single infusion of 5 x 10\^8 viable CTL019 transduced cells, which was administered via intravenous infusion. The acceptable dose range was 1 - 5x10\^8 viable CTL019 transduced cells.

DRUG

Lymphodepleting chemotherapy

Prior to CTL019 cell infusion, an additional lymphodepleting chemotherapy cycle was planned. The use of any additional bridging therapy prior to the recommended lymphodepleting chemotherapy was at the discretion of the investigator and dependent on the patient's disease burden. Lymphodepleting chemotherapy was started 14 to 5 days before CTL019 infusion (D1) to allow for at least 48 hours from last dose of lymphodepleting chemotherapy to CTL019 infusion. The lymphodepleting regimen was: Fludarabine (25 mg/m\^2 intravenously \[i.v.\] daily for 3 doses) and cyclophosphamide (250 mg/m\^2 i.v. daily for 3 doses starting with the first dose of fludarabine).

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-29
Primary Completion
2022-12-22
Completion
2022-12-22
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands
  • Norway

Study Locations

More Related Trials

Entities

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 NCT02445248 on ClinicalTrials.gov