Multi-Modality Imaging and Correlative Studies in Patients With Leukemia

Who is this study for? Adult patients with Acute Myeloid Leukemia or Acute Lymphocytic Leukemia
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other, Drug
Study Type: Interventional
Study Phase: Early Phase 1
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 irradiation (TBI) and chemotherapy. Using multi-modality imaging and collecting biospecimen samples may help doctors know more about how TBI and chemotherapy can change the bone marrow.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
City of Hope Medical Center
RECRUITING
Duarte
Time Frame
Start Date: 2018-02-15
Estimated Completion Date: 2025-11-06
Participants
Target number of participants: 74
Treatments
Experimental: Cohort I (TMLI+FLT/TMLI)
Patients may undergo optional fluorothymidine F-18 PET scan over 2 hours at baseline, on days 30 and 100, at 1 year, and at time of relapse. Patients undergo DECT and water-fat MRI scan over 30 minutes at baseline, on days 30 and 100, at year 1, and at time of relapse. Patients also undergo collection of bone marrow and blood samples at baseline, on days 30 and 100, and at 1 year. Patients undergo fluorothymidine F-18 PET, DECT, and water-fat MRI as in TMLI+FLT.
Active_comparator: Cohort II (TBI)
Patients undergo collection of bone marrow at baseline, day 30, time of relapse, and at 1 year.
Authors
Jeffrey Wong
Sponsors
Leads: City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov