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

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ClinicalTrials.gov Identifier: NCT04888338
Recruitment Status : Recruiting
First Posted : May 17, 2021
Last Update Posted : November 26, 2021
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment
Hematopoietic and Lymphoid Cell Neoplasm 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) 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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcomes After Chimeric Antigen Receptor Therapy (CAR-T) and Radiation Therapy (RT) for Hematologic Malignancies
Actual Study Start Date : April 10, 2021
Estimated Primary Completion Date : November 14, 2022
Estimated Study Completion Date : November 14, 2022
Groups and Cohorts
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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)


Outcome Measures
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Primary Outcome Measures :
  1. Clinical outcomes of patients with hematologic malignancies receiving standard-of-care chimeric antigen receptor therapy (CAR-T) and radiation therapy (RT) [ Time Frame: 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 :
  1. Patient-specific factors and treatment-related factors [ Time Frame: 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

  2. Relationship between radiation dose, target, technique, and timing with respect to CAR-T and clinical outcomes [ Time Frame: 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

  3. Relationship between patient-specific factors and treatment-related factors and treatment toxicity [ Time Frame: 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04888338


Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Penny Q. Fang, MD    832-260-1389    pfang@mdanderson.org   
Principal Investigator: Penny Q. Fang, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Penny Q Fang M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04888338    
Other Study ID Numbers: 2020-1150
NCI-2021-00910 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2020-1150 ( Other Identifier: M D Anderson Cancer Center )
First Posted: May 17, 2021    Key Record Dates
Last Update Posted: November 26, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases