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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 is a Phase 1 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 89 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01898793
The ClinicalTrials.gov registry entry for NCT01898793 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 89 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 5 interventions - of which Cyclophosphamide is the first listed.
NCT01898793 reports 0 study locations.
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.
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