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NCT02316964 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), sponsored by Sumithira Vasu.

Completed
Registry status
Phase 1
Development phase
8
Enrollment target
1
Study location

NCT02316964: Completed Phase 1 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), sponsored by Sumithira Vasu.

NCT02316964 is a Phase 1 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) that has completed, run by Sumithira Vasu. The registered enrollment target is 8 participants, below the 118-participant average among 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02316964, a Phase 1 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), has completed, sponsored by Sumithira Vasu.

COMPLETED
Registry status
Phase 1
Development phase
8 participants
Enrollment target
1
Study location

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.

Primary Outcome

Will be summarized descriptively. Infusion toxicity and tolerability will be summarized by frequencies of type of reaction and will be tabulated for each cohort of patients treated under a specific approach and manufacturing process.

Conditions Studied

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) Adult Acute Myeloid Leukemia With Del(5q) Recurrent Adult Acute Myeloid Leukemia Secondary 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
Sumithira Vasu

6 total trials

What the finished NCT02316964 record still lists

NCT02316964 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 118-participant average among 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials with a reported enrollment target (93% lower).

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.

NCT02316964 reports a single indexed study location in Ohio.

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).

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).

Who is sponsoring clinical trial NCT02316964?

This trial is sponsored by Sumithira Vasu, which has 6 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

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Where NCT02316964's enrollment target sits among peer trials

8 28th of 29 higher than 2 of 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities 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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Related registry views

Source: ClinicalTrials.gov NCT02316964, the US trial registry maintained by the National Library of Medicine. NCT02316964 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.