Status:
RECRUITING
Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Bone Marrow Changes in Patients With Acute Myeloid Leukemia Undergoing TBI and Chemotherapy
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This clinical trial investigates multi-modality imaging and collection of biospecimen samples in understanding bone marrow changes in patients with acute myeloid leukemia undergoing total body irradia...
Detailed Description
PRIMARY OBJECTIVES: I. Temporal assessment of treatment impact on bone marrow. II. Relative assessment of bone marrow status between total marrow and lymphoid irradiation (TMLI) and conventional TBI....
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Cohort TMLI+FLT: AML patients eligible for and enrolling on COH 14012 or IRB 17505 that agree to participate in optional FLT PET imaging
- Note: patients enrolling on IRB 19518 cannot enroll onto this cohort, but they may enroll on Cohort TMLI (below)
- Cohort TMLI: AML or ALL patients eligible for and enrolling on COH 14012, IRB 17505 or IRB 19518
- Cohort TBI: First or second remission AML or ALL patients that will receive TBI (13.2 Gy) plus chemotherapy (etoposide \[VP16\] 60 mg/kg or cyclophosphamide \[Cy\] 60 mg/kg for two days) as part of their standard of care
- Cohort TBI: Documented written informed consent of participant
- Cohort TBI: Age \>= 18 to =\< 60 years
- Cohort TBI: Patients who have not received a prior transplant
Exclusion
Key Trial Info
Start Date :
February 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 6 2026
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT03422731
Start Date
February 15 2018
End Date
November 6 2026
Last Update
November 19 2025
Active Locations (1)
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1
City of Hope Medical Center
Duarte, California, United States, 91010