Diffuse Large B-Cell LymphomaNCT07103486
A Study to Evaluate the Therapeutic Benefit of Tisagenlecleucel Compared to Existing Standard of Care in German Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
An observational study of Diffuse Large B-Cell Lymphoma, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
The aim of this study was to evaluate the therapeutic benefit of tisagenlecleucel compared to the existing standard of care in adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). For tisagenlecleucel patients, patient-level data from the JULIET study (CTL019C2201) was used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma
- Type of treatment
- Injection or infusion
- How many people
- 264 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study.
Who may be able to join
- Aged 18 years or older.
- Histologically confirmed DLBCL, transformed indolent Non-Hodgkin Lymphoma (NHL) was also allowed (such as transformed follicular lymphoma).
- r/r DLBCL after 2 or more chemotherapy lines, including rituximab and anthracycline. Previous autologous hematopoietic stem cell transplantation (HSCT) was allowed. For transformed indolent NHL, anthracycline treatment before transformation was allowed.
- Had received patient-individual therapy in the qualifying line(s) (3rd or to a maximum of 9th line). Patient-individual therapy was chosen in consideration of molecular genetic lymphoma characteristics, previous therapies, disease history and patient's general condition, including an allogeneic HSCT where possible. Best supportive care in the palliative setting was also a treatment option.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Even if no ECOG performance status or Karnofsky Index was documented in patient charts the patient could be eligible for documentation.
- Had adequate organ function at the discretion of the treating physician:
- Adequate pulmonary reserve (e.g. ≤ Grade 1 dyspnea and pulse oxygenation > 91 % on room air)
- Hemodynamically stable and adequate cardiac function (e.g. Left Ventricular Ejection Fraction (LVEF) ≥ 45 %)
Who cannot join
- Received more than 8 treatment lines before qualifying treatment failure.
- Active central nervous system (CNS) involvement by malignancy.
- Had prior allogeneic HSCT.
- Human immunodeficiency virus (HIV)-positive patients.
- Had uncontrolled, acutely life-threatening bacterial, viral or mycotic infections (e.g. blood culture positive ≤ 72 hours before treatment start).
- Had unstable angina pectoris and/or myocardial infarct within 6 months before qualifying treatment failure.
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- Had previous or concurrent malignant tumor disease with some exceptions (basal cell or squamous cell carcinoma, curatively treated in-situ carcinoma of the cervix or breast, curatively treated primary malignant tumor disease in complete remission for ≥ 5 years).
- Had cardiac arrhythmias that could not be controlled with drug treatment.
- Patients with T-cell-rich/histiocyte-rich large B-cell lymphoma (THRBCL), primary cutaneous large B-cell lymphoma, primary mediastinal B-cell lymphoma (PMBCL), Epstein Barr virus (EBV)-positive DLBCL in the elderly, Richter's transformation, and Burkitt lymphoma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Chart Review for German Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) After Two or More Lines of Systemic Therapy With Subsequent Historical Comparison Against Tisagenlecleucel Based on JULIET Trial (CTL019C2201)
The aim of this study was to evaluate the therapeutic benefit of tisagenlecleucel compared to the existing standard of care in adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). For tisagenlecleucel patients, patient-level data from the JULIET study (CTL019C2201) was used. Data for patients treated with the appropriate comparator therapy (ACT) in German routine care was collected via chart review by 8 medical centers in Germany. The medical charts provided data on adult patients at the time of the qualifying treatments in the time period from approximately 2010 to 2017 with the longest possible follow-up phases (up to 5 years, but only until December 31, 2020).
- Conditions
- Diffuse Large B-Cell Lymphoma
- Keywords
- Relapsed, Refractory
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tisagenlecleucel Full Analysis Set (FAS) Group | Adult patients with r/r DLBCL who were enrolled in the JULIET trial and received an infusion of tisagenlecleucel. | |
| Tisagenlecleucel Intention To Treat (ITT) Group | Adult patients with r/r DLBCL who were enrolled in the JULIET trial. | |
| External Control Group | Adult patients with r/r DLBCL after two or more lines of chemotherapy. Patient data was collected from German medical center chart reviews. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
For the external control and tisagenelcleucel FAS groups: OS was defined as the time from the date of treatment start to the date of death due to any cause and censored otherwise.
For the tisagenelcleucel ITT group: OS was defined as the time from the date of enrollment to the date of death due to any cause and censored otherwise.
Measured: Up to approximately 5 years
Progression-free Survival (PFS)
For the external control and tisagenelcleucel FAS groups: PFS was defined as the time from the date of treatment start to the date of first documented disease progression or death due to any cause and censored otherwise.
For the tisagenelcleucel ITT group: PFS was defined as the time from the date of enrollment to the date of first documented disease progression or death due to any cause and censored otherwise.
Measured: Up to approximately 5 years
Event-free Survival (EFS)
For the external control and tisagenelcleucel FAS groups: EFS was defined as the time from the date of treatment start to the date of first documented disease progression or relapse, new treatment for lymphoma or death due to any cause and censored otherwise.
For the tisagenelcleucel ITT group: EFS was defined as the time from the date of enrollment to the date of first documented disease progression or relapse, new treatment for lymphoma or death due to any cause.
Measured: Up to approximately 5 years
Overall Response Rate (ORR)
ORR was defined as the proportion of patients with a best overall disease response of complete response (CR) or partial response (PR), respectively until progressive disease or start of new anticancer therapy, whichever came first. CR and PR efficacy evaluation was based on Cheson Response Criteria and The Lugano Classification (2014).
Measured: Up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Apr 2021
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103486
- Sponsor's protocol ID
- CCTL019CDE01
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Chart Review for German Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) After Two or More Lines of Systemic Therapy With Subsequent Historical Comparison Against Tisagenlecleucel Based on JULIET Trial (CTL019C2201)
- ClinicalTrials.gov ID
- NCT07103486
- Acronym / sponsor ID
- CCTL019CDE01
- Conditions
- Diffuse Large B-Cell Lymphoma
- Keywords
- Relapsed, Refractory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to evaluate the therapeutic benefit of tisagenlecleucel compared to the existing standard of care in adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). For tisagenlecleucel patients, patient-level data from the JULIET study (CTL019C2201) was used. Data for patients treated with the appropriate comparator therapy (ACT) in German routine care was collected via chart review by 8 medical centers in Germany. The medical charts provided data on adult patients at the time of the qualifying treatments in the time period from approximately 2010 to 2017 with the longest possible follow-up phases (up to 5 years, but only until December 31, 2020).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tisagenlecleucel Full Analysis Set (FAS) Group | – | –Adult patients with r/r DLBCL who were enrolled in the JULIET trial and received an infusion of tisagenlecleucel. |
| Tisagenlecleucel Intention To Treat (ITT) Group | – | –Adult patients with r/r DLBCL who were enrolled in the JULIET trial. |
| External Control Group | – | –Adult patients with r/r DLBCL after two or more lines of chemotherapy. Patient data was collected from German medical center chart reviews. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study.
Key inclusion criteria (8 listed)
- Aged 18 years or older.
- Histologically confirmed DLBCL, transformed indolent Non-Hodgkin Lymphoma (NHL) was also allowed (such as transformed follicular lymphoma).
- r/r DLBCL after 2 or more chemotherapy lines, including rituximab and anthracycline. Previous autologous hematopoietic stem cell transplantation (HSCT) was allowed. For transformed indolent NHL, anthracycline treatment before transformation was allowed.
- Had received patient-individual therapy in the qualifying line(s) (3rd or to a maximum of 9th line). Patient-individual therapy was chosen in consideration of molecular genetic lymphoma characteristics, previous therapies, disease history and patient's general condition, including an allogeneic HSCT where possible. Best supportive care in the palliative setting was also a treatment option.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Even if no ECOG performance status or Karnofsky Index was documented in patient charts the patient could be eligible for documentation.
Key exclusion criteria (9 listed)
- Received more than 8 treatment lines before qualifying treatment failure.
- Active central nervous system (CNS) involvement by malignancy.
- Had prior allogeneic HSCT.
- Human immunodeficiency virus (HIV)-positive patients.
- Had uncontrolled, acutely life-threatening bacterial, viral or mycotic infections (e.g. blood culture positive ≤ 72 hours before treatment start).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival (OS)
Time frame: Up to approximately 5 years
For the external control and tisagenelcleucel FAS groups: OS was defined as the time from the date of treatment start to the date of death due to any cause and censored otherwise. For the tisagenelcleucel ITT group: OS was defined as the time from the date of enrollment to the date of death due to any cause and censored otherwise.
Progression-free Survival (PFS)
Time frame: Up to approximately 5 years
For the external control and tisagenelcleucel FAS groups: PFS was defined as the time from the date of treatment start to the date of first documented disease progression or death due to any cause and censored otherwise. For the tisagenelcleucel ITT group: PFS was defined as the time from the date of enrollment to the date of first documented disease progression or death due to any cause and censored otherwise.
Event-free Survival (EFS)
Time frame: Up to approximately 5 years
For the external control and tisagenelcleucel FAS groups: EFS was defined as the time from the date of treatment start to the date of first documented disease progression or relapse, new treatment for lymphoma or death due to any cause and censored otherwise. For the tisagenelcleucel ITT group: EFS was defined as the time from the date of enrollment to the date of first documented disease progression or relapse, new treatment for lymphoma or death due to any cause.
Overall Response Rate (ORR)
Time frame: Up to approximately 5 years
ORR was defined as the proportion of patients with a best overall disease response of complete response (CR) or partial response (PR), respectively until progressive disease or start of new anticancer therapy, whichever came first. CR and PR efficacy evaluation was based on Cheson Response Criteria and The Lugano Classification (2014).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large B-Cell Lymphoma, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to approximately 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.