Anti-Leukemia Immune Responses After Irradiation of Extramedullary Tumors
Primary Purpose
Acute Myeloid Leukemia, Myeloid Leukemia, Recurrent Acute Myeloid Leukemia
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Biopsy
Biospecimen Collection
Electronic Health Record Review
Photography
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia
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
Sites / Locations
- M D Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (biopsy, biospecimen collection)
Arm Description
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.
Outcomes
Primary Outcome Measures
Changes in anti-leukemia immune responses
Secondary Outcome Measures
Full Information
NCT ID
NCT05035706
First Posted
August 25, 2021
Last Updated
October 5, 2023
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05035706
Brief Title
Anti-Leukemia Immune Responses After Irradiation of Extramedullary Tumors
Official Title
Anti-Leukemia Immune Responses After Irradiation of Extramedullary Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Myeloid Leukemia, Recurrent Acute Myeloid Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment (biopsy, biospecimen collection)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Biopsy
Other Intervention Name(s)
BIOPSY_TYPE, Bx
Intervention Description
Undergo biopsy
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Other Intervention Name(s)
Biological Sample Collection
Intervention Description
Undergo blood and tissue sample collection
Intervention Type
Other
Intervention Name(s)
Electronic Health Record Review
Intervention Description
Medical records reviewed
Intervention Type
Other
Intervention Name(s)
Photography
Intervention Description
Photographs taken
Primary Outcome Measure Information:
Title
Changes in anti-leukemia immune responses
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bouthaina S Dabaja
Phone
713-563-2406
Email
bdabaja@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bouthaina S Dabaja
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bouthaina S. Dabaja
Phone
713-563-2406
Email
bdabaja@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Bouthaina S. Dabaja
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center
Learn more about this trial
Anti-Leukemia Immune Responses After Irradiation of Extramedullary Tumors
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