Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Bone Marrow Changes… (NCT03422731) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Bone Marrow Changes in Patients With Acute Myeloid Leukemia Undergoing TBI and Chemotherapy
United States82 participantsStarted 2018-02-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change over time in cellularity and adiposity
Timeframe: Up to 1 year post-hematopoietic stem cell transplant (HCT)
2
Change over time of red marrow (cellularity) and yellow marrow (adipocyte)
Timeframe: Up to 2 years
3
Number of hematopoietic stem cell (HSC) colony forming units (sub-analysis)
Timeframe: Up to 2 years
4
Ratio of HSC sub-populations (sub-analysis)
Timeframe: Up to 2 years
5
Hematopoietic stem cell density in bone marrow biopsy samples (sub-analysis)
Timeframe: Up to 2 years
6
Microvascular density in bone marrow biopsy samples (sub-analysis)