Anti-Leukemia Immune Responses After Irradiation of Extramedullary Tumors

Acute Myeloid Leukemia Clinical Trial

Official title:

Anti-Leukemia Immune Responses After Irradiation of Extramedullary Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05035706
• Other study ID #: 2021-0037
• Secondary ID: NCI-2021-0868520
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 30, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: October 2023
• Source: M.D. Anderson Cancer Center
• Contact: Bouthaina S Dabaja
• Phone: 713-563-2406
• Email: bdabaja[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Biopsy
Undergo biopsy
• Biospecimen Collection
Undergo blood and tissue sample collection

Other:
• Electronic Health Record Review
Medical records reviewed
• Photography
Photographs taken

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in anti-leukemia immune responses		Through study completion, an average of 1 year

External Links

•   M D Anderson Cancer Center