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NCT01390311 · ClinicalTrials.gov registry record · Phase 1
Azacitidine After Chemotherapy and Donor Lymphocyte Infusion in Patients With Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome Previously Treated With Donor Stem Cell Transplant
A Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT01390311 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 14 participants.
The verdict
NCT01390311, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Azacitidine
- BIOLOGICAL Donor Leukocyte Infusion (DLI)
- DRUG Pre-DLI Salvage Chemotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2012-04 |
| Est. Completion | 2015-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01390311
The ClinicalTrials.gov registry entry for NCT01390311 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Azacitidine is the first listed.
NCT01390311 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01390311 about?
NCT01390311 is a clinical study titled "Azacitidine After Chemotherapy and Donor Lymphocyte Infusion in Patients With Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome Previously Treated With Donor Stem Cell Transplant". 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...
What is the current status of trial NCT01390311?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2012-04. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01390311?
The interventions under investigation include: Azacitidine (DRUG), Donor Leukocyte Infusion (DLI) (BIOLOGICAL), Pre-DLI Salvage Chemotherapy (DRUG).
Who is sponsoring clinical trial NCT01390311?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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