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Blood Samples to Identify Biomarkers for Post-Transplant Cyclophosphamide
This trial uses blood samples to understand how patients' bodies process and respond to a drug called cyclophosphamide given after a donor stem cell transplant. Identifying biomarkers (molecules that can indicate normal or abnormal processes) may help researchers develop a blood test that can be used to predict how well patients will process and respond to cyclophosphamide.
"Ancillary-Correlative" study type PRIMARY OBJECTIVES: I. To determine whether endogenous metabolomics compounds obtained before cyclophosphamide administration can predict the ratio of 4hydroxycyclophosphamide to cyclophosphamide area under the curve (4HCY/CY AUC). II. To evaluate mathematic models of CY and mycophenolic acid (MPA) pharmacokinetics and develop mathematic models including these pharmacokinetics, -omics data and clinical outcomes. SECONDARY OBJECTIVES: I. To assess if recipients' metabolomics and pharmacokinetics (e.g., CY and its metabolites AUCs) are associated with acute graft versus host disease (GVHD) and other clinical outcomes. II. To assess the association of the intestinal microbiome with the plasma metabolome, acute GVHD and other clinical outcomes. III. To obtain donor blood samples at one time pre-transplant and assess if donors' metabolomics are associated with acute GVHD and other clinical outcomes. EXPLORATORY OBJECTIVE: I. Donor and recipient germline deoxyribonucleic acid (DNA) isolation and genomic analysis. OUTLINE: Participants are assigned to 1 of 2 arms. ARM I (PATIENTS RECEIVING A HAPLOIDENTICAL TRANSPLANT): Patients undergo collection of blood prior to transplant, on day 0, days 3-7, day 14, and day 21. Patients also undergo collection of saliva prior to transplant and collection of stool prior to and post-transplant. Donors undergo collection of blood and saliva within 8 weeks prior to donation.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
City of Hope Medical Center
Duarte, California, United States
Start Date
November 13, 2018
Primary Completion Date
April 24, 2027
Completion Date
April 24, 2027
Last Updated
July 28, 2025
72
ACTUAL participants
Biospecimen Collection-Blood
OTHER
Biospecimen Collection-Stool
OTHER
Lead Sponsor
City of Hope Medical Center
Collaborators
NCT00026884
NCT07453927
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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