Anti-Leukemia Immune Responses After Irradiation of Extramedullary Tumors
2 other identifiers
interventional
10
1 country
1
Brief Summary
This clinical trial assesses how the immune system responds to leukemia tumors after low dose radiation delivered as part of standard of care. The information learned in this study may help them know if adding immunotherapy (a type of treatment that uses the immune system to fight cancer) can be helpful in future leukemia patients receiving radiation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Jun 2021
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 30, 2021
CompletedFirst Submitted
Initial submission to the registry
August 25, 2021
CompletedFirst Posted
Study publicly available on registry
September 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2026
CompletedMarch 5, 2026
March 1, 2026
4.8 years
August 25, 2021
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in anti-leukemia immune responses
Through study completion, an average of 1 year
Study Arms (1)
Treatment (biopsy, biospecimen collection)
EXPERIMENTALPatients undergo biopsy prior to radiation therapy and 7-14 days after radiation therapy. Patients also undergo blood sample collection prior to therapy (within 7 days of starting radiation therapy), 1 and 7 days post completion of radiation therapy. Patients' photographs of the biopsy site are taken before and at 4-6 weeks post completion of radiation, and their medical records are reviewed for up to 2 years.
Interventions
Undergo biopsy
Undergo blood and tissue sample collection
Medical records reviewed
Eligibility Criteria
You may qualify if:
- Patients diagnosed with new or recurrent myeloid leukemia
- Aged \>= 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status \< 4
- Patient have measurable and amenable to biopsy under local anesthesia without the need for imaging directed procedure
- Ability to understand and provide signed informed consent
- Females must be surgically or biologically sterile or postmenopausal (amenorrhoeic for at least 12 months) or if of childbearing potential, must have a negative serum or urine pregnancy test within 72 hours before the start of the treatment. Women of childbearing potential must agree to use an adequate method of contraception during the study and until the last radiation treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study and until the last radiation treatment
You may not qualify if:
- Patients who are unwilling to participate
- Patients unwilling to undergo the biopsy before or after radiotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bouthaina S Dabaja
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2021
First Posted
September 5, 2021
Study Start
June 30, 2021
Primary Completion
April 30, 2026
Study Completion
April 30, 2026
Last Updated
March 5, 2026
Record last verified: 2026-03