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Anti-Leukemia Immune Responses After Irradiation of Extramedullary Tumors

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05035706
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
34
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Biopsy
  • Procedure: Biospecimen Collection
  • Other: Electronic Health Record Review
  • Other: Photography
 Early Phase 1

Detailed Description

PRIMARY OBJECTIVES:

  1. To identify changes in anti-leukemia immune responses after local radiotherapy to extramedullary sites.

  2. 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.

  3. Define changes in the T cell receptor (TCR) clonotypes, functionality and inflammatory cytokine levels in peripheral blood leukocytes and serum.

  4. Correlate changes in anti-tumor immune responses with clinic-pathological variables and patient outcomes.

SECONDARY OBJECTIVES:

  1. To assess the overall response rate (ORR= complete response [CR] + partial response [PR]) of the extramedullary tumor treated with radiation therapy.

  2. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Anti-Leukemia Immune Responses After Irradiation of Extramedullary Tumors
Actual Study Start Date :
Jun 30, 2021
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Procedure: Biopsy
Undergo biopsy
Other Names:
  • BIOPSY_TYPE
  • Bx

    • Procedure: Biospecimen Collection
    Undergo blood and tissue sample collection
    Other Names:
  • Biological Sample Collection

    • Other: Electronic Health Record Review
    Medical records reviewed

    Other: Photography
    Photographs taken

    Outcome Measures

    Primary Outcome Measures

    1. Changes in anti-leukemia immune responses [Through study completion, an average of 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center

    Investigators

    • Principal Investigator: Bouthaina S Dabaja, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05035706
    Other Study ID Numbers:
    • 2021-0037
    • NCI-2021-08685
    • 2021-0037
    First Posted:
    Sep 5, 2021
    Last Update Posted:
    Sep 16, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myeloid
    Leukemia, Myeloid, Acute

    Study Results

    No Results Posted as of Sep 16, 2021