Anti-Leukemia Immune Responses After Irradiation of Extramedullary Tumors

NCT ID: NCT05035706

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2026-04-30

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (biopsy, biospecimen collection)

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.

Group Type: EXPERIMENTAL

Biopsy

Intervention Type: PROCEDURE

Undergo biopsy

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo blood and tissue sample collection

Electronic Health Record Review

Intervention Type: OTHER

Medical records reviewed

Photography

Intervention Type: OTHER

Photographs taken

Interventions

Biopsy

Undergo biopsy

Intervention Type: PROCEDURE

Biospecimen Collection

Undergo blood and tissue sample collection

Intervention Type: PROCEDURE

Electronic Health Record Review

Medical records reviewed

Intervention Type: OTHER

Photography

Photographs taken

Intervention Type: OTHER

Other Intervention Names

BIOPSY_TYPE; Bx; Biological Sample Collection

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Patients who are unwilling to participate
• Patients unwilling to undergo the biopsy before or after radiotherapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bouthaina S Dabaja

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

NCI-2021-08685

Identifier Type: REGISTRY

Identifier Source: secondary_id

2021-0037

Identifier Type: OTHER

Identifier Source: secondary_id

2021-0037

Identifier Type: -

Identifier Source: org_study_id