Secondary Malignancies of T-cell OriginLythesiaNCT07378969
A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy
An observational study of Secondary Malignancies of T-cell Origin, run by Novartis Pharmaceuticals at 4 sites in Japan.
Trial summary
The study aims to provide an adequate procedural framework to support and facilitate collection of existing participant samples from patients who were diagnosed with secondary malignancy of T-cell origin any time after tisagenlecleucel treatment for testing of muCAR19 transgene and RCL, as well as additional analyses… Read more about this study
- Who is it for?
- Ages 15 to 15 years
- Conditions the study is for
- Secondary Malignancies of T-cell Origin
- How many people
- 30 participants
- Where
- 4 sitesJapan
- Study dates
- 23 Mar 2026to 31 Aug 2039
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 15 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: patients who were diagnosed with secondary malignancy of T-cell origin any time after tisagenlecleucel treatment
Who may be able to join
- Study participants eligible for inclusion in this study must meet all of the following criteria:
- Prior use of tisagenlecleucel treatment in CTL019 clinical trial setting or post-marketing/commercial tisagenlecleucel setting as outlined for Cohort 1 and Cohort 2
- Confirmed diagnosis of secondary malignancy of T-cell origin via redacted pathology report and/or clinical confirmation by the Principal Investigator/clinician responsible for enrolling the participant. Clinical judgement may be required in cases where the diagnosis is not clearly confirmed in the redacted pathology report. There also may be cases in certain site/countries, where sharing the redacted pathology reports is not allowed, hence the clinical diagnosis will be allowed for eligibility.
- Availability of existing secondary malignancy of T cell origin specimen(s) from tissue, and/or bone marrow aspirate sample(s) and/or blood or DNA extracted from blood (with confirmed T-cell malignancy diagnosis in the sample provided) collected during routine standard of care during the secondary malignancy of T-cell origin diagnosis. Often, only a limited amount of the appropriate sample(s) may be available. For the testing process, a specimen containing the malignant T-cells for the secondary malignancy of T-cell origin must be present. The type of specimen/sample for testing is determined based on the location of the secondary malignancy of T-cell origin. For example, bone marrow aspirate and/or blood and/or bone marrow biopsy may be needed for analysis for a secondary malignancy of T cell origin when the malignant T cells are present in blood and/or bone marrow, and tissue such as a lymph node location or cutaneous or other location is needed when this is the region of the body affected by the secondary malignancy of T-cell origin. Blood, (even if NOT involved with the T cell malignant cells) when available, may also be used for comparison to the tissue/bone marrow used for the analysis. Novartis has established ranges of CAR transgene level in blood for all 3 pivotal trial indications at specific time points. This is used for comparison.
- See laboratory manual for detailed instructions. The following types of samples are recommended for collection if available/pre-existing:
- Tumor tissue (FFPE block (ambient temp), unstained slides (ambient temp), or bone marrow aspirate in EDTA or blood in EDTA and frozen, if malignant T-cells present)
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- Peripheral blood EDTA frozen- to be used when available and either not involved with T-cell malignancy for comparison to the tumor sample provided and/or if peripheral blood has circulating malignant T cells for analysis.
- Bone marrow aspirate EDTA frozen if involved with secondary malignancy of T-cell origin.
- DNA extracted from blood or bone marrow aspirate stored frozen
- Bone marrow biopsy if malignant T-cells are present (FFPE block, unstained slides, ambient temperature)
- Signed informed consent. For participants who have died, it is acceptable for clinical/academic sites to use a previous biospecimen research consent, or to have an appropriate family member or designated representative to provide consent on behalf of the participant as per local regulations.
Who cannot join
- Study participants meeting any of the following criteria are not eligible for inclusion in this study:
- Ongoing enrollment on Novartis sponsored CTL019 interventional or LTFU clinical trial
- Cases where there is no existing available specimens that include the secondary malignancy of T cell origin (tumor tissue and/or existing blood and/or bone marrow and/or DNA from blood for testing)
- Cases where informed consent is not possible.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
Japan4 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Bunkyo Ku, Tokyo, 1138677
- Active, not recruiting
Novartis Investigative Site
Kurume, Fukuoka, 830-8543
- Recruiting
Novartis Investigative Site
Osaka, Osaka, 5418567
- Recruiting
Novartis Investigative Site
Suita, Osaka, 565-0871
About this study
Official title: A Non-Interventional Study (NIS) PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy (CCTL019B2402)
The study aims to provide an adequate procedural framework to support and facilitate collection of existing participant samples from patients who were diagnosed with secondary malignancy of T-cell origin any time after tisagenlecleucel treatment for testing of muCAR19 transgene and RCL, as well as additional analyses as warranted. Formal testing of existing tumor tissue and/or blood DNA will assess a potential role of tisagenlecleucel in the development/oncogenesis of secondary malignancy of T-cell origin.
Read the detailed description
The participant population will include individuals who have been treated either in the post-marketing/commercial setting (Cohort 2) or in the clinical trial setting (Cohort 1) but discontinued from the primary interventional study trials, did not move to the LTFU study, or discontinued from the long-term follow-up (LTFU) clinical trial CCTL019A2205B and have a confirmed secondary malignancy of T-cell origin.
The study will remain open for the enrollment of participants from Cohort 1 and Cohort 2 for up to approximately 15 years from the last indication approved for tisagenlecleucel.
- Conditions
- Secondary Malignancies of T-cell Origin
- Keywords
- NIS, PASS, secondary malignancies of T-cell origin, tisagenlecleucel
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 |
|---|---|---|
| Cohort 1 | Individuals who have been treated with tisagenlecleucel in the clinical trial setting but discontinued from the primary interventional study trials, did not move to the long-term follow-up study, or discontinued from the long-term follow-up | |
| Cohort 2 | Cohort 2 includes participants who received tisagenlecleucel in the post-marketing/commercial setting, including patients who received out of specification (OOS) product, or patients enrolled into a MAP (Managed Access Program) or IIT (Investigator Initiated Trial). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of muCAR19 qPCR and VCN positive tumors
Test specific participant samples using qPCR for muCAR19 transgene/VCN to determine whether the tumor is positive for the muCAR19 transgene with sufficiently positive VCN (≥0.1 viral copies/cell). In cases where there is insufficient DNA to perform qPCR, or when the tumor tissue contains bone (such as bone marrow biopsy), IHC will be performed when feasible. The presence of bone in the sample precludes isolation of DNA of appropriate quality to perform qPCR. In cases where muCAR19 transgene copies are not detectable per qPCR, and/or IHC for muCAR19 is negative, no further testing is performed
Measured: At screening
Average vector copy number (VCN) and replication competent lentivirus (RCL) among confirmed secondary primary malignancy tumors
Average vector copy number (VCN) and replication competent lentivirus (RCL) among confirmed secondary primary malignancy tumors from patients exposed to tisagenlecleucel.
Measured: At screening
Number of participants with positive muCAR19 IHC and LISA Test
For cases where the qPCR for muCART19 is positive in the tumor tissue and the calculated VCN would suggest the presence of a muCAR19 positive tumor, or for positive muCAR19 IHC, LISA will be performed if adequate sample is available
Measured: At screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start23 Mar 2026
- Primary completion31 Aug 2039 (estimated)
- Study completion31 Aug 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Malignancies of T-cell OriginStudies 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
- Prospective
- Enrolment
- 30 participants (estimated)
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
- NCT07378969
- Sponsor's protocol ID
- CCTL019B2402
- Other IDs
- EUPAS1000000749
- Acronym
- Lythesia
- Status last verified
- Jun 2026
- First submitted
- 23 Jan 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional Study (NIS) PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy (CCTL019B2402)
- ClinicalTrials.gov ID
- NCT07378969
- Acronym / sponsor ID
- Lythesia / CCTL019B2402
- Conditions
- Secondary Malignancies of T-cell Origin
- Keywords
- NIS, PASS, secondary malignancies of T-cell origin, tisagenlecleucel
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- 31 Aug 2039 (estimated)
- Study completion
- 31 Aug 2039 (estimated)
- First posted
- 30 Jan 2026 (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 study aims to provide an adequate procedural framework to support and facilitate collection of existing participant samples from patients who were diagnosed with secondary malignancy of T-cell origin any time after tisagenlecleucel treatment for testing of muCAR19 transgene and RCL, as well as additional analyses as warranted. Formal testing of existing tumor tissue and/or blood DNA will assess a potential role of tisagenlecleucel in the development/oncogenesis of secondary malignancy of T-cell origin.
Detailed description
The participant population will include individuals who have been treated either in the post-marketing/commercial setting (Cohort 2) or in the clinical trial setting (Cohort 1) but discontinued from the primary interventional study trials, did not move to the LTFU study, or discontinued from the long-term follow-up (LTFU) clinical trial CCTL019A2205B and have a confirmed secondary malignancy of T-cell origin.
The study will remain open for the enrollment of participants from Cohort 1 and Cohort 2 for up to approximately 15 years from the last indication approved for tisagenlecleucel.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Individuals who have been treated with tisagenlecleucel in the clinical trial setting but discontinued from the primary interventional study trials, did not move to the long-term follow-up study, or discontinued from the long-term follow-up |
| Cohort 2 | – | –Cohort 2 includes participants who received tisagenlecleucel in the post-marketing/commercial setting, including patients who received out of specification (OOS) product, or patients enrolled into a MAP (Managed Access Program) or IIT (Investigator Initiated Trial). |
Who may qualify
- Ages
- 15 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- patients who were diagnosed with secondary malignancy of T-cell origin any time after tisagenlecleucel treatment
Key inclusion criteria (11 listed)
- Study participants eligible for inclusion in this study must meet all of the following criteria:
- Prior use of tisagenlecleucel treatment in CTL019 clinical trial setting or post-marketing/commercial tisagenlecleucel setting as outlined for Cohort 1 and Cohort 2
- Confirmed diagnosis of secondary malignancy of T-cell origin via redacted pathology report and/or clinical confirmation by the Principal Investigator/clinician responsible for enrolling the participant. Clinical judgement may be required in cases where the diagnosis is not clearly confirmed in the redacted pathology report. There also may be cases in certain site/countries, where sharing the redacted pathology reports is not allowed, hence the clinical diagnosis will be allowed for eligibility.
- Availability of existing secondary malignancy of T cell origin specimen(s) from tissue, and/or bone marrow aspirate sample(s) and/or blood or DNA extracted from blood (with confirmed T-cell malignancy diagnosis in the sample provided) collected during routine standard of care during the secondary malignancy of T-cell origin diagnosis. Often, only a limited amount of the appropriate sample(s) may be available. For the testing process, a specimen containing the malignant T-cells for the secondary malignancy of T-cell origin must be present. The type of specimen/sample for testing is determined based on the location of the secondary malignancy of T-cell origin. For example, bone marrow aspirate and/or blood and/or bone marrow biopsy may be needed for analysis for a secondary malignancy of T cell origin when the malignant T cells are present in blood and/or bone marrow, and tissue such as a lymph node location or cutaneous or other location is needed when this is the region of the body affected by the secondary malignancy of T-cell origin. Blood, (even if NOT involved with the T cell malignant cells) when available, may also be used for comparison to the tissue/bone marrow used for the analysis. Novartis has established ranges of CAR transgene level in blood for all 3 pivotal trial indications at specific time points. This is used for comparison.
- See laboratory manual for detailed instructions. The following types of samples are recommended for collection if available/pre-existing:
Key exclusion criteria (4 listed)
- Study participants meeting any of the following criteria are not eligible for inclusion in this study:
- Ongoing enrollment on Novartis sponsored CTL019 interventional or LTFU clinical trial
- Cases where there is no existing available specimens that include the secondary malignancy of T cell origin (tumor tissue and/or existing blood and/or bone marrow and/or DNA from blood for testing)
- Cases where informed consent is not possible.
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
Percentage of muCAR19 qPCR and VCN positive tumors
Time frame: At screening
Test specific participant samples using qPCR for muCAR19 transgene/VCN to determine whether the tumor is positive for the muCAR19 transgene with sufficiently positive VCN (≥0.1 viral copies/cell). In cases where there is insufficient DNA to perform qPCR, or when the tumor tissue contains bone (such as bone marrow biopsy), IHC will be performed when feasible. The presence of bone in the sample precludes isolation of DNA of appropriate quality to perform qPCR. In cases where muCAR19 transgene copies are not detectable per qPCR, and/or IHC for muCAR19 is negative, no further testing is performed
Average vector copy number (VCN) and replication competent lentivirus (RCL) among confirmed secondary primary malignancy tumors
Time frame: At screening
Average vector copy number (VCN) and replication competent lentivirus (RCL) among confirmed secondary primary malignancy tumors from patients exposed to tisagenlecleucel.
Number of participants with positive muCAR19 IHC and LISA Test
Time frame: At screening
For cases where the qPCR for muCART19 is positive in the tumor tissue and the calculated VCN would suggest the presence of a muCAR19 positive tumor, or for positive muCAR19 IHC, LISA will be performed if adequate sample is available
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Secondary Malignancies of T-cell Origin, run by Novartis Pharmaceuticals at 4 sites in Japan.
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 11 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+81337978748, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of muCAR19 qPCR and VCN positive tumors (time frame: At screening). The study lists 3 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 11 Jun 2026.