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COMPLETED Phase 1

Decitabine, Donor Natural Killer Cells, and Aldesleukin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

NCT02316964 · View on ClinicalTrials.gov ↗

Study Summary

This pilot trial studies decitabine, donor natural killer cells, and aldesleukin in treating patients with acute myeloid leukemia that has come back after previous treatment (relapsed) or has not responded to previous treatment (refractory). Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving donor natural killer cells after decitabine may boost the patient's immune system by helping it see the remaining cancer cells as not belonging in the patient's body and causing it to destroy them (called graft-versus-tumor effect). Aldesleukin may stimulate natural killer cells to kill acute myeloid leukemia cells. Giving decitabine, donor natural killer cells, and aldesleukin may be a better treatment for acute myeloid leukemia.

Interventions

  • OTHER laboratory biomarker analysis
  • DRUG decitabine
  • BIOLOGICAL aldesleukin
  • BIOLOGICAL natural killer cell therapy

Study Locations (1)

Ohio

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center — Columbus

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2015-04-21
Est. Completion 2019-12-20
Phase Phase 1

Sponsor

Sumithira Vasu

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02316964

The ClinicalTrials.gov registry entry for NCT02316964 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sumithira Vasu, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 8 conditions, with Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities appearing as the primary indexed condition, and to 4 interventions — of which laboratory biomarker analysis is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02316964 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02316964 about?

NCT02316964 is a clinical study titled "Decitabine, Donor Natural Killer Cells, and Aldesleukin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia". This pilot trial studies decitabine, donor natural killer cells, and aldesleukin in treating patients with acute myeloid leukemia that has come back after previous treatment (relapsed) or has not responded to previous treatment (refractory). Drugs used in chemotherapy, such as decitabine, work in di...

What is the current status of trial NCT02316964?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2015-04-21. Estimated completion is 2019-12-20.

What conditions does trial NCT02316964 study?

This clinical trial studies the following conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02316964?

The interventions under investigation include: laboratory biomarker analysis (OTHER), decitabine (DRUG), aldesleukin (BIOLOGICAL), natural killer cell therapy (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02316964?

This trial is sponsored by Sumithira Vasu, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02316964 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial