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

Hematopoietic and Lymphoid Cell Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04888338
• Other study ID #: 2020-1150
• Secondary ID: NCI-2021-0091020
• Status: Recruiting
• Start date: April 10, 2021
• Est. completion date: November 14, 2026

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 14, 2026
• Est. primary completion date: November 14, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematopoietic and Lymphoid Cell Neoplasm

Intervention

Other:
• Data Capture
Treatment related data is collected
• Electronic Medical Record
Medical records are reviewed

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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

External Links

•   M D Anderson Cancer Center website