Understanding bone marrow changes in leukemia patients undergoing treatment
Multi-Modality Imaging and Correlative Studies in Patients With Leukemia
This study is testing how different types of radiation and chemotherapy affect the bone marrow of patients with acute myeloid leukemia during treatment.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT03422731 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates how total body irradiation (TBI) and chemotherapy affect bone marrow in patients with acute myeloid leukemia (AML) through multi-modality imaging and biospecimen collection. It aims to assess the temporal impact of treatment on bone marrow and compare the effects of total marrow and lymphoid irradiation (TMLI) versus conventional TBI. The study includes two cohorts, one undergoing optional fluorothymidine F-18 PET scans and the other receiving standard TBI treatment. The trial also explores correlations between imaging results and biological samples to better understand treatment responses.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 60 with acute myeloid leukemia or acute lymphoblastic leukemia who are eligible for TBI and chemotherapy.
Not a fit: Patients who have received prior transplants or are outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effects of treatment on bone marrow, potentially leading to improved therapeutic strategies for leukemia patients.
How similar studies have performed: Other studies have shown promise in using imaging techniques to assess treatment effects in leukemia, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Duarte, California
- City of Hope Medical Center — Duarte, California, United States (Recruiting)
Study contacts
- Principal investigator: Jeffrey Y Wong — City of Hope Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.