Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients (JULIET)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02445248 |
|
Recruitment Status :
Completed
First Posted : May 15, 2015
Results First Posted : April 18, 2024
Last Update Posted : April 18, 2024
|
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Study Type | Interventional |
|---|---|
| Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Diffuse Large B-cell Lymphoma (DLBCL) |
| Interventions |
Biological: Tisagenlecleucel Drug: Lymphodepleting chemotherapy |
| Enrollment | 115 |
Participant Flow
| Recruitment Details | 115 participants were infused in this study: 99 in the Main Cohort and 16 in Cohort A. |
| Pre-assignment Details |
After informed consent/assent was obtained, and prior to infusion, participants underwent a routine lymphodepleting therapy, 14 to 5 days before CTL019 infusion. There were 27 centers across 10 countries for this trial. |
| Arm/Group Title | Tisagenlecleucel - Main Cohort | Tisagenlecleucel Cohort A |
|---|---|---|
 Arm/Group Description |
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US. | Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany. |
| Period Title: Overall Study | ||
| Started [1] | 99 | 16 |
| Completed [2] | 26 | 3 |
| Not Completed | 73 | 13 |
| Reason Not Completed | ||
| Death | 45 | 12 |
| Progressive disease | 13 | 1 |
| Subject decision | 8 | 0 |
| Physician Decision | 5 | 0 |
| Adverse Event | 1 | 0 |
| Lost to Follow-up | 1 | 0 |
|
[1]
Started = Infused
[2]
Completed = Study follow-up completed
|
||
Baseline Characteristics
| Arm/Group Title | Tisagenlecleucel - Main Cohort | Tisagenlecleucel Cohort A | Total | |
|---|---|---|---|---|
|
Arm/Group Description |
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US. | Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 99 | 16 | 115 | |
|
Baseline Analysis Population Description |
Full analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel.
|
|||
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
| Number Analyzed | 99 participants | 16 participants | 115 participants | |
| 54.3 (13.09) | 51.1 (12.98) | 53.8 (13.07) | ||
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 99 participants | 16 participants | 115 participants | |
| Female |
36 36.4%
|
8 50.0%
|
44 38.3%
|
|
| Male |
63 63.6%
|
8 50.0%
|
71 61.7%
|
|
|
Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 99 participants | 16 participants | 115 participants |
| White | 83 | 15 | 98 | |
| Asian | 10 | 0 | 10 | |
| Black | 4 | 0 | 4 | |
| Other | 2 | 1 | 3 | |
|
ECOG performance status
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 99 participants | 16 participants | 115 participants |
| ECOG status of 0 | 54 | 11 | 65 | |
| ECOG status of 1 | 45 | 5 | 50 | |
|
[1]
Measure Description: The Eastern Cooperative Oncology Group (ECOG) Performance status is a numbering scale used in Oncology w to define the population of patients to study in the trial and guide physicians who enroll patients into those studies. The lower the number the better the performance status of the patient, where 0: Fully active, able to carry on all pre-disease performance without restriction. ECOG Performance status of 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
|
||||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e., data from all sites) in clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
| Name/Title: | Clinical Disclosure Office |
| Organization: | Novartis Pharmaceuticals |
| Phone: | 862-778-3000 |
| EMail: | novartis.email@novartis.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT02445248 |
| Other Study ID Numbers: |
CCTL019C2201 2014-003060-20 ( EudraCT Number ) |
| First Submitted: | May 5, 2015 |
| First Posted: | May 15, 2015 |
| Results First Submitted: | December 16, 2023 |
| Results First Posted: | April 18, 2024 |
| Last Update Posted: | April 18, 2024 |