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

NCT04160390 | Active Not Recruiting

• 3 other identifiers: 18358NCI-2019-07376U01CA239373
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Allogeneic Hematopoietic Stem Cell Transplant Recipient; Donor; Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• Mathematical models of cyclophosphamide (CY) and mycophenolic acid pharmacokinetics (PK) with t cell effects.

  Will determine whether readily available patient characteristics influence CY PK using population (pop)PK modeling. Will validate our existing popPK model of CY, 4HCY, and carboxyethylphosphoramide mustard.

  Up to day 21

Secondary Outcomes (1)

• Acute GVHD

  Up to 4 years

Study Arms (1)

Arm I (biospecimen collection)

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.

Other: Biospecimen Collection-Blood; Other: Biospecimen Collection-Stool

Interventions

Biospecimen Collection-Blood OTHER

Undergo collection of blood

Arm I (biospecimen collection)

Biospecimen Collection-Stool OTHER

Undergo collection of stool

Arm I (biospecimen collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of the City of Hope Comprehensive Cancer Center and donors.

You may qualify if:

• Scheduled to undergo allogeneic hematopoietic cell transplant (HCT) with a haploidentical donor.
• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, saliva, stool

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jeannine S McCune

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 13, 2019
• Study Start: November 13, 2018
• Primary Completion (Estimated): April 24, 2027
• Study Completion (Estimated): April 24, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

US (1)