Outcomes After Chimeric Antigen Receptor Therapy and Radiation Therapy for Hematologic Malignancies

Study Overview
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Brief Summary
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This study collects information on outcomes after chimeric antigen receptor therapy and radiation therapy for hematologic malignancies. Collecting information from patients before, during, and after receiving chimeric antigen receptor therapy or radiation therapy may help doctors to optimize patient selection, dose, timing, and sequencing of these treatments.

Detailed Description
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PRIMARY OBJECTIVE: I. Record clinical outcomes of patients with hematologic malignancies receiving standard-of-care chimeric antigen receptor therapy (CAR-T) and radiation therapy (RT). SECONDARY OBJECTIVES: I. To record patient-specific factors and treatment-related factors in patients with hematologic malignancies receiving standard-of-care CAR-T and RT to ultimately improve patient selection and overall treatment strategy to optimize clinical outcomes. II. To record and explore the relationship between radiation dose, target, technique, and timing with respect to CAR-T and clinical outcomes in patients with hematologic malignancies treated with standard-of-care CAR-T and RT. III. To record and study the relationship between patient-specific factors and treatment-related factors and treatment toxicity in patients with hematologic malignancies undergoing standard-of-care CAR-T and RT. OUTLINE: Patients medical records are reviewed for details about CAR-T and RT treatment and acute and late toxicities, disease outcomes such as any events related to local or distant disease progression, survival, and cause of death if available. Patients' imaging scan data is collected at baseline, within 2 months of the first treatment of RT or CAR-T, and at 3, 6, 12 months, and then annually for 5 years after RT completion.

Official Title
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Outcomes After Chimeric Antigen Receptor Therapy (CAR-T) and Radiation Therapy (RT) for Hematologic Malignancies

Conditions
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Hematopoietic and Lymphoid Cell Neoplasm

Intervention / Treatment
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* Other: Data Capture
* Other: Electronic Medical Record


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Treatment with or intention to treat with radiation therapy and standard-of-care CAR-T cell therapy within a 90 day window for a hematologic malignancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (data collection)<br>Patients medical records are reviewed for details about CAR-T and RT treatment and acute and late toxicities, disease outcomes such as any events related to local or distant disease progression, survival, and cause of death if available. Patients' imaging scan data is collected at baseline, within 2 months of the first treatment of RT or CAR-T, and at 3, 6, 12 months, and then annually for 5 years after RT completion. | Other: Data Capture<br>* Treatment related data is collected<br>Other: Electronic Medical Record<br>* Medical records are reviewed<br>* Other names: EMR (electronic medical record);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcomes of patients with hematologic malignancies receiving standard-of-care chimeric antigen receptor therapy (CAR-T) and radiation therapy (RT) | Outcome measures will include the following: date and type of disease progression, time to lymphoma progression, progression confirmed on biopsy (yes/no), disease control within the radiation field, survival and date of death, cause of death, overall response rate/best response achieved, duration of response, Toxicities including adverse events (CTCAE v 5.0), Neurotoxicity (ICANS) and cytokine release syndrome grade | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-specific factors and treatment-related factors | Patient- and treatment-related outcome measures include the following: Type of hematologic malignancy, disease stage, presence of bulky and/or extranodal disease, number of prior lines of therapy, treatment with prior stem cell transplant, radiation treatment dose/fractionation, target, technique, timing of radiation relative to CAR-T cell therapy, type of CAR-T cell therapy, bridging and conditioning therapy received, laboratory studies including LDH and CRP | Up to 5 years | 
| Relationship between radiation dose, target, technique, and timing with respect to CAR-T and clinical outcomes | Correlation between radiation dose, target, technique, and timing with respect to CAR-T and clinical outcomes. Radiation details include the following: radiation treatment dose/fractionation, target, technique, timing of radiation relative to CAR-T cell therapy, radiation treatment intent. Clinical outcome measures include the following: date and type of disease progression, time to lymphoma progression, progression confirmed on biopsy (yes/no), disease control within the radiation field, survival and date of death, cause of death, overall response rate/best response achieved, duration of response, Toxicities including adverse events (CTCAE v 5.0), Neurotoxicity (ICANS) and cytokine release syndrome grade | Up to 5 years | 
| Relationship between patient-specific factors and treatment-related factors and treatment toxicity | Patient and treatment-related factors include the following: Type of hematologic malignancy, disease stage, presence of bulky and/or extranodal disease, number of prior lines of therapy, treatment with prior stem cell transplant, radiation treatment dose/fractionation, target, technique, timing of radiation relative to CAR-T cell therapy, type of CAR-T cell therapy, bridging and conditioning therapy received, laboratory studies including LDH and CRP Treatment toxicity includes the following: adverse events (CTCAE v 5.0), Neurotoxicity (ICANS) and cytokine release syndrome grade | Up to 5 years |