Outcomes After Chimeric Antigen Receptor Therapy and Radiation Therapy for Hematologic Malignancies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
Patients who are receiving CAR-T cell therapy or radiation therapy for hematologic malignancy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Data Capture
Other interventionTreatment related data is collected
Electronic Medical Record
Other interventionMedical records are reviewed
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Observational (data collection)2 interventions
Trial outcomes
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
Time frame
Up to 5 yearsSecondary outcomes
1
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
Time frame
Up to 5 years2
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
Time frame
Up to 5 years3
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
Time frame
Up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov