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NCT01898793 · ClinicalTrials.gov registry record · Phase 1
Cytokine-induced Memory-like NK Cells in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
A Phase 1 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 89
- Enrollment target
NCT01898793: Clinical Trial Phase 1 study, sponsored by Washington University School of Medicine.
NCT01898793 is a Phase 1 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 89 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01898793, a Phase 1 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 89 participants
- Enrollment target
Study Summary
This phase I/2 trial studies the side effects and best dose of activated natural killer cells in treating patients with relapsed or refractory acute myeloid leukemia and myelodysplastic syndromes. Giving chemotherapy before a donor natural killer cell infusion helps stop the growth of cancer cells and stops the patient's immune system from rejecting the donor's natural killer cells. Modified natural killer cells may help the body build an immune response to kill cancer cells. Aldesleukin (interleukin-2) may stimulate the white blood cells (including natural killer cells) to kill leukemia cells. In the phase II and pediatric portion of the study, the investigators intend to use maximal tolerated or tested (MT/TD) CIML NK cell dose as determined from the phase I part of this study. The phase II portion of the study also replaces IL-2 with ALT-803. The rationale for this change is to support the donor derived NK cells in vivo after adoptive transfer. With amendment 16, the decision was made to return to the use of rhIL-2 support instead of ALT-803.
Primary Outcome
Defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity (DLT) or the maximum dose if less than or equal to 1 patient suffers a DLT at the maximum dose.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- PROCEDURE Leukapheresis
- BIOLOGICAL IL-2
- BIOLOGICAL Cytokine-induced killer cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2014-08-11 |
| Est. Completion | 2022-04-04 |
| Phase | Phase 1 |
Why NCT01898793 stopped before completion
NCT01898793 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% higher).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01898793 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01898793 about?
NCT01898793 is a clinical study titled "Cytokine-induced Memory-like NK Cells in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)". This phase I/2 trial studies the side effects and best dose of activated natural killer cells in treating patients with relapsed or refractory acute myeloid leukemia and myelodysplastic syndromes. Giving chemotherapy before a donor natural killer cell infusion helps stop the growth of cancer cells a...
What is the current status of trial NCT01898793?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 89 participants. The study started on 2014-08-11. Estimated completion is 2022-04-04.
What interventions are being tested in trial NCT01898793?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Leukapheresis (PROCEDURE), IL-2 (BIOLOGICAL), Cytokine-induced killer cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT01898793?
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 NCT01898793's enrollment target sits among peer trials
89 649th of 2000 higher than 1,351 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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