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

NCT04888338 | Recruiting FDA Drug

• 2 other identifiers: 2020-1150NCI-2021-00910
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patient-specific factors and treatment-related factors

  Up to 5 years

• Relationship between radiation dose, target, technique, and timing with respect to CAR-T and clinical outcomes

  Up to 5 years

• Relationship between patient-specific factors and treatment-related factors and treatment toxicity

  Up to 5 years

Study Arms (1)

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; Other: Electronic Medical Record

Interventions

Data Capture OTHER

Treatment related data is collected

Observational (data collection)

Electronic Medical Record OTHER

Medical records are reviewed

Also known as: Computer Based Patient Record, EMR, EMR (electronic medical record)

Observational (data collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center website

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Electronic Health Records

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Medical Records Systems, Computerized; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Penny Q Fang

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Penny Q Fang, MD

CONTACT

713-563-2345; pfang@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: May 17, 2021
• Study Start: April 10, 2021
• Primary Completion (Estimated): November 14, 2026
• Study Completion (Estimated): November 14, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)