Clinical trial · Observational
Retrospective Study of Immunotherapy Related Toxicities and Factors Impacting Outcomes in Children and Adults With Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Immunotherapy is changing the landscape of cancer therapy. Particularly unique to immunotherapy is the toxicity profile, which differs from chemotherapy-based strategies and can be associated with inflammatory responses and/or autoimmune type reactions resulting from activation of the immune system. Referred to as immune related adverse events (irAEs), these adverse events may require systemic immunosuppression or have other consequences and present unique management challenges. Specific to CAR T-cell and other adoptive cell therapies is the constellation of symptoms referred to as cytokine release syndrome (CRS), which can range in severity from mild to severe, and can require both cytokine directed blockade and/or systemic immunosuppression to ameliorate the side effects. While side effects may be unique to each individual immunotherapy, and may also be patient specific, cumulative experience will help to inform toxicity profiles and improve management of side effects and overall outcomes. Given the number of immunotherapeutic approaches at the NCI, the primary goal of this protocol is to facilitate retrospective chart review of various immunotherapy trials at the NCI used in the treatment of cancer to comprehensively study toxicity profiles. This study will not involve the use of specimens or participant contact. All data that is needed has already been collected on the individual treatment protocols and is available in CRIS records or protocol specific databases. Data will only be collected from treatment protocols where the PI has given permission for use of the data on the trial the subject was enrolled on. This protocol will be amended to incorporate new research objectives and new protocols as necessary.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Macrophage Activation Syndrome | — | UNRESOLVED | — |
| Primary Hemophagocytic Lymphohistiocytosis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- Retrospective chart review of children and adults with cancer enrolled on immunotherapy treatment protocols in the NCI.
Primary outcomes (1)
- measure
- To develop a retrospective study to allow for comparison of immunotherapy related toxicity profiles and risk factors across a set of protocols in the NCI.
- timeFrame
- 2 years
- description
- Summary of immunotherapy related toxicity profiles and risk factors across a set of protocols in the NCI.
Secondary outcomes (24)
- measure
- Evaluate infectious complications and their risk factors in patients who receive CAR-T cell therapy for cancer
- timeFrame
- 2 years
- description
- Summary of infectious complications and their risk factors in patients who receive CAR-T cell therapy for cancer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 120 Years
Show eligibility criteria text
* Retrospective chart review of various immunotherapy trials at the NCI used in the treatment of cancer to comprehensively study toxicity profiles. This study will not involve the use of specimens or participant contact. All data that is needed has already been collected on the individual treatment protocols and is available in CRIS records or protocol specific databases.
References
Publications (3)
- DERIVEDCulbert AA, Gava F, Valtis YK, Satta T, Vora S, Rocco JM, Nussenblatt V, Silbert SK, Shalabi H, Yates B, Park JH, Lamble AJ, Rejeski K, Shah NN. Pre-infusion risk factors predict severe infectious complications of CAR T-cell therapy in pediatric and adult patients with B-ALL. J Immunother Cancer. 2025 Sep 14;13(9):e012436. doi: 10.1136/jitc-2025-012436. PMID 40953923
- DERIVEDSilbert SK, Madan S, Holland EM, Steinberg SM, Little L, Foley T, Epstein M, Sarkisian A, Lee DW, Nikitina E, Kakumanu S, Ruppin E, Shalabi H, Yates B, Shah NN. A comprehensive analysis of adverse events in the first 30 days of phase 1 pediatric CAR T-cell trials. Blood Adv. 2023 Sep 26;7(18):5566-5578. doi: 10.1182/bloodadvances.2023009789. PMID 37486616
- DERIVEDHolland EM, Yates B, Steinberg SM, Yuan CM, Wang HW, Annesley C, Shalabi H, Stroncek D, Fry TJ, Krueger J, Jacoby E, Hsieh E, Bhojwani D, Gardner RA, Maude SL, Shah NN. Chimeric Antigen Receptor T Cells as Salvage Therapy for Post-Chimeric Antigen Receptor T Cell Failure. Transplant Cell Ther. 2023 Sep;29(9):574.e1-574.e10. doi: 10.1016/j.jtct.2023.06.019. Epub 2023 Jun 30. PMID 37394115