Characterizing secondary T‑cell cancers after tisagenlecleucel

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a non‑interventional post‑authorization safety surveillance program enrolling people who developed a confirmed secondary T‑cell malignancy after receiving tisagenlecleucel in either clinical trials (Cohort 1) or the commercial setting (Cohort 2). The study collects existing tumor tissue, bone marrow aspirates, blood, or extracted DNA and performs targeted testing for the muCAR19 transgene, replication‑competent lentivirus (RCL), and additional genomic analyses as warranted. Enrollment is open for up to about 15 years from the last approved indication and uses centralized laboratory testing and clinical review to interpret results. No investigational treatments are given; the work is observational sample testing to explore possible links between therapy and secondary T‑cell oncogenesis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Study participants eligible for inclusion in this study must meet all of the following criteria:

1. Prior use of tisagenlecleucel treatment in CTL019 clinical trial setting or post-marketing/commercial tisagenlecleucel setting as outlined for Cohort 1 and Cohort 2
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.
3. 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.

   Additional details will be provided in the laboratory manual; however, the recommended sample types for collection (if available/pre-existing) are listed below:
   1. 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)
   2. 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.
   3. Bone marrow aspirate EDTA frozen if involved with secondary malignancy of T-cell origin.
   4. DNA extracted from blood or bone marrow aspirate stored frozen
   5. Bone marrow biopsy if malignant T-cells are present (FFPE block, unstained slides, ambient temperature)
4. 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.

Exclusion Criteria:

Study participants meeting any of the following criteria are not eligible for inclusion in this study:

1. Ongoing enrollment on Novartis sponsored CTL019 interventional or LTFU clinical trial
2. 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)
3. Cases where informed consent is not possible.

Where it's running

• Novartis Investigative Site
  Osaka, Osaka, Japan Recruiting
• Novartis Investigative Site
  Suita, Osaka, Japan Recruiting
• Novartis Investigative Site
  Bunkyo Ku, Tokyo, Japan Recruiting
• Novartis Investigative Site
  Kurume, Fukuoka, Japan Completed

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +81337978748

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• XEP527 in stable schizophrenia: safety and how it behaves in the body

  This small, early-stage study tests the safety and how XEP527 behaves in people with stable schizophrenia who are on a single antipsychotic.

  Recruiting Phase 1 Novartis · Bentonville, Arkansas · NCT07908680

• BTK inhibitor remibrutinib in hidradenitis suppurativa shows how it works in adults

  This phase 1 trial tests whether remibrutinib can safely affect HS in adults with moderate to severe disease.

  Recruiting at 2 sites Phase 1 Novartis · San Diego, California and 1 other locations · NCT07855276

• Dose-finding test of YMI024 in adults with stable coronary artery disease and high hsCRP

  This study tests several doses of YMI024 to see if it reduces inflammation and is safe for adults with stable CAD and elevated hsCRP, compared to placebo.

  Recruiting at 23 sites Phase 2 Novartis · Fairhope, Alabama and 22 other locations · NCT07830719

• Remibrutinib and omalizumab-based treatment approach for adults with chronic spontaneous urticaria not well controlled by antihistamines

  This trial tests a sequencing plan using remibrutinib and omalizumab to see if it helps adults with chronic spontaneous urticaria that isn’t well controlled by second-generation antihistamines.

  Recruiting at 10 sites Phase 3 Novartis · London, Ontario and 9 other locations · NCT07816328

• Single-dose combination therapy for uncomplicated malaria in young children

  This study tests whether a single oral dose of a combination of anti-malarial drugs can cure uncomplicated Plasmodium falciparum malaria in children aged 2 to under 12 years, compared with standard Coartem treatment.

  Recruiting at 5 sites Phase 2 Novartis · Banfora and 12 other locations · NCT07811908

• Remibrutinib for Severe Chronic Pruritus of Unknown Origin in Adults

  We’re testing whether remibrutinib can help adults with severe, unexplained itching that hasn’t gone away with moisturizers.

  Recruiting at 12 sites Phase 3 Novartis · Fremont, California and 11 other locations · NCT07811869

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.