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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm
• Intervention / Treatment: Other: Data Capture; Other: Electronic Medical Record

Detailed Description

PRIMARY OBJECTIVE:

I. Record clinical outcomes of patients with hematologic malignancies receiving standard-of-care chimeric antigen receptor therapy (CAR-T) nd/or standard-of- care bispecific therapy, 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/or standard-of-care bispecific therapy, 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/or standard-of-care bispecific therapy and clinical outcomes in patients with hematologic malignancies treated with standard-of-care CAR-T, and/ or standard-of-care bispecific therapy, 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/or standard-of-care bispecific therapy, 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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Penny Q Fang, MD; Phone Number: 713-563-2345; Email: pfang@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Penny Q. Fang, MD; Phone Number: 832-260-1389; Email: pfang@mdanderson.org
      • Principal Investigator: Penny Q. Fang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who are receiving CAR-T cell therapy or radiation therapy for hematologic malignancy

Description

Inclusion Criteria:

• Age 18 years or older
• Treatment with or intention to treat with radiation therapy, standard-of-care CAR-T cell therapy and/or standard-of-care bispecific therapy, within a 90 day window for a hematologic malignancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observational (data collection); 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; Treatment related data is collected; Other: Electronic Medical Record; Medical records are reviewed; Other Names: Computer Based Patient Record; EMR; EMR (electronic medical record)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Penny Q Fang, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center website

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2021
• Primary Completion (Estimated): November 14, 2026
• Study Completion (Estimated): November 14, 2026

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms; Organization and Administration; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Records; Medical Records Systems, Computerized; Medical Records; Electronic Health Records
• Other Study ID Numbers: 2020-1150 (Other Identifier: M D Anderson Cancer Center); NCI-2021-00910 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No