NCT05035706

Anti-Leukemia Immune Responses After Irradiation of Extramedullary Tumors

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To identify changes in anti-leukemia immune responses after local radiotherapy to extramedullary sites. II. Develop an annotated biospecimen panel of extramedullary leukemia biopsies prior to and after radiotherapy to examine local immune responses using transcriptional profiling, immunofluorescence and single cell analyses. III. Define changes in the T cell receptor (TCR) clonotypes, functionality and inflammatory cytokine levels in peripheral blood leukocytes and serum. IV. Correlate changes in anti-tumor immune responses with clinic-pathological variables and patient outcomes. SECONDARY OBJECTIVES: I. To assess the overall response rate (ORR= complete response \[CR\] + partial response \[PR\]) of the extramedullary tumor treated with radiation therapy. II. To assess the CR of extramedullary tumor treated with radiation therapy. III. Determine the duration of response (DOR), event-free survival (EFS). OUTLINE: Patients 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.

Conditions

• Acute Myeloid Leukemia
• Myeloid Leukemia
• Recurrent Acute Myeloid Leukemia

Interventions

Type	Name	Description
PROCEDURE	Biopsy	Undergo biopsy
PROCEDURE	Biospecimen Collection	Undergo blood and tissue sample collection
OTHER	Electronic Health Record Review	Medical records reviewed
OTHER	Photography	Photographs taken

Timeline

• Start date: 2021-06-30
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2021-09-05
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States