Clinical trial NCT04888338: Outcomes After Chimeric Antigen Receptor Therapy and Radiation Therapy for Hematologic Malignancies
Official title: Outcomes After Chimeric Antigen Receptor Therapy (CAR-T) and Radiation Therapy (RT) for Hematologic Malignancies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are receiving CAR-T cell therapy or radiation therapy for hematologic malignancy

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) 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical outcomes of patients with hematologic malignancies receiving standard-of-care chimeric antigen receptor therapy (CAR-T) and radiation therapy (RT)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Patient-specific factors and treatment-related factors
timeFrame: Up to 5 years
measure: Relationship between radiation dose, target, technique, and timing with respect to CAR-T and clinical outcomes
timeFrame: Up to 5 years
measure: Relationship between patient-specific factors and treatment-related factors and treatment toxicity
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Penny Q Fang
role: PRINCIPAL_INVESTIGATOR
References: