Anti-Leukemia Immune Responses After Irradiation of Extramedullary Tumors

April 17, 2024 updated by: M.D. Anderson Cancer Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Bouthaina S. Dabaja

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Other: Electronic Health Record Review
Medical records reviewed
Procedure: Biopsy
Undergo biopsy
Other Names:
  • Bx
  • BIOPSY_TYPE
Procedure: Biospecimen Collection
Undergo blood and tissue sample collection
Other Names:
  • Biological Sample Collection
Other: Photography
Photographs taken

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in anti-leukemia immune responses
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2021

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

August 25, 2021

First Submitted That Met QC Criteria

August 30, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0037 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2021-08685 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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