Clinical trialNCT01390311CompletedPhase 1Interventional

Azacitidine After Chemotherapy and Donor Lymphocyte Infusion in Patients With Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome Previously Treated With Donor Stem Cell Transplant

SponsorWashington University School of MedicineEnrollment14Leukemia, Myeloid, AcuteMyelodysplastic Syndromes

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This phase I trial studies the effects and safety of adding azacitidine (5-AzaC) to the standard of care (Soc) for patients with relapsed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after being treated with donor stem cell transplant. SoC includes giving an infusion of the donor's white blood cells (donor lymphocyte infusion or DLI) to boost the anticancer effects of the transplant. Giving 5-AzaC after DLI may alter the function of T-cells resulting in reduced incidence of graft versus host disease (GVHD) while maintaining the anticancer effects.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Peter Westervelt, M.D., Ph.D.
Washington University School of Medicine
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Washington University School of Medicine
St Louis, Missouri, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Azacitidine →Donor Leukocyte InfusionPre-DLI Salvage Chemotherapy

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Apr 2012
Primary completion: 31 Mar 2014
Completion: 30 Apr 2015
Last update posted: 27 Apr 2015
Registered enrollment: 14
Registry id: NCT01390311

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.