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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: Completed Phase 1 study, sponsored by Washington University School of Medicine.
NCT01390311 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
MTD is defined as the maximum dose level immediately below the dose level at which 2 patients of a cohort (3 to 6 patients) experience dose-limiting toxicity during the first cycle.
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 |
What the finished NCT01390311 record still lists
NCT01390311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which Azacitidine is the first listed.
NCT01390311 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01390311's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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