Clinical trial · Observational
Blood Samples to Identify Biomarkers in Patients Treated With Cyclophosphamide After Donor Stem Cell Transplant
Blood Samples to Identify Biomarkers for Post-Transplant Cyclophosphamide
NCT04160390CI-TRIAL-00119597active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Allogeneic Hematopoietic Stem Cell Transplant Recipient | — | UNRESOLVED | — |
| Donor | — | UNRESOLVED | — |
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection-Blood | Other | — | UNRESOLVED |
| Biospecimen Collection-Stool | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Arm I (biospecimen collection)
- description
- 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.
- interventionNames
- Other: Biospecimen Collection-Blood
- Other: Biospecimen Collection-Stool
Primary outcomes (1)
- measure
- Mathematical models of cyclophosphamide (CY) and mycophenolic acid pharmacokinetics (PK) with t cell effects.
- timeFrame
- Up to day 21
- description
- 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.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.