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

Recruiting

• Conditions: Hematopoietic and Lymphoid Cell Neoplasm
• Interventions: Other: Data Capture; Other: Electronic Medical Record

• Registration Number: NCT04888338
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-02-24
• Study Start: 2021-04-10
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03
• Primary Completion: 2026-11-14
• Study Completion: 2026-11-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (data collection)	Data Capture	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.
Observational (data collection)	Electronic Medical Record	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.

Primary Outcome Measures

Name	Time	Method
Clinical outcomes of patients with hematologic malignancies receiving standard-of-care chimeric antigen receptor therapy (CAR-T) and radiation therapy (RT)	Up to 5 years	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

Secondary Outcome Measures

Name	Time	Method
Relationship between radiation dose, target, technique, and timing with respect to CAR-T and clinical outcomes	Up to 5 years	"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
Patient-specific factors and treatment-related factors	Up to 5 years	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
Relationship between patient-specific factors and treatment-related factors and treatment toxicity	Up to 5 years	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

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States