Blood Samples to Identify Biomarkers in Patients Treated With Cyclophosphamide After Donor Stem Cell Transplant

  • STATUS
    Recruiting
  • End date
    Oct 24, 2023
  • participants needed
    60
  • sponsor
    City of Hope Medical Center
Updated on 14 June 2022
cyclophosphamide
treatment regimen
primary cancer
Accepts healthy volunteers

Summary

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.

Description

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 validate 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 it's 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.

ARM II (PATIENTS RECEIVING A NON-HAPLOIDENTICAL TRANSPLANT): Patients undergo collection of blood prior to transplant and on days 0, 3, and 4. Patients also undergo collection of stool prior to and post-transplant. Donors undergo collection of blood and saliva within 8 weeks prior to donation.

Details
Condition Allogeneic Hematopoietic Stem Cell Transplant Recipient, Donor, Malignant Neoplasm
Treatment biospecimen collection, Biospecimen Collection-Blood, Biospecimen Collection-Stool
Clinical Study IdentifierNCT04160390
SponsorCity of Hope Medical Center
Last Modified on14 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Scheduled to undergo first allogeneic hematopoietic cell transplant (HCT)
Allogeneic HCT scheduled to treat any underlying disease. Patients with nonmalignant diseases or cancer are eligible
Scheduled to receive post-transplant cyclophosphamide (any dose, any number of doses, any dosing frequency) as part of their post-graft immunosuppression or GVHD prophylaxis. Patients enrolled on treatment protocols that include post transplant cyclophosphamide (PTCy) but do not include mycophenolate mofetil (MMF) or tacrolimus can participate
Willingness to
Provide blood
Permit medical record review
Clear my responses

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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