Retrospective Study of Immunotherapy Related Toxicities and Factors Impacting Outcomes in Children and Adults With Cancer

Brief Summary

Detailed Description

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 or from standard of care protocols. This protocol will be amended to incorporate new research objectives and new protocols as necessary.

Primary Outcomes

Secondary Outcomes

• To evaluate outcomes of CAR T-cells based on time of infusion(2 years)
• Evaluate relationship between clinical variable and apheresis and manufacturing products(2 years)
• Evaluate incidence of hypertension, identify risk factors for development of hypertension, summarize medical management in CAR setting, and identify complications(2 years)
• Evaluate infectious complications and their risk factors in patients who receive CAR-T cell therapy for cancer(2 years)
• Evaluate the incidence, risk factors for, and treatment of HLH/MAS (now renamed IEC-HS) in patients who receive CAR-T cell therapy.(2 years)
• Incidence and time to resolution(2 years)
• Overall and relapse free survival(2 years)
• Incidence of end organ toxicities(2 years)
• Evaluate response and toxicity profile of second CAR T-cell infusions(2 years)
• Evaluate impact of race/ethnicity and obesity on CAR T-cell outcomes(2 years)
• Evaluate impact of cryopreservation on outcomes following CAR T-cell infusion(2 years)
• Evaluate outcomes for patients with ALL and Down Syndrome following CAR T-cell therapy(2 years)
• Evaluate absolute lymphocyte count following lymphodepleting chemotherapy(2 years)
• Describe baseline demographics, prior treatment characteristics and outcomes based on patients who are referred to CAR T-cell program(2 years)
• Incidence of pre-infusion BCA and use of BCA as a prognostic marker for CAR T-cell associated toxicity and efficacy(2 years)
• Presence and durability of CD72 expression in both B-ALL and normal B-ALL/hematogones(2 years)
• Evaluate interventions, documentation of care goals, and use of palliative care consultation or other symptom management(2 years)
• Evaluate the role of manufacturing changes on CAR T-cell outcomes(2 Years)
• Evaluate CAR T-cell related coagulopathies(2 Years)
• Evaluate long-term outcomes of survivors who received CAR T-cell therapy(2 years)
• Evaluate the use of anti-cytokine therapy to treat toxicities after CAR T-cell infusion(2 Years)
• Evaluate outcomes of CAR T-cells in patients with extramedullary disease(2 Years)
• Evaluate cross compare responses and outcomes based on NGS MRD and FC MRD(2 Years)
• Evaluate the impact of clonal hematopoiesis on CAR T-cell outcomes(2 Years)