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NCT02484391 · ClinicalTrials.gov registry record · Phase 1

CPI-613, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Granulocytic Sarcoma

A Phase 1 study of Recurrent Adult Acute Myeloid Leukemia and Granulocytic Sarcoma, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
Phase 1
Development phase
48
Enrollment target
1
Study location

NCT02484391: Completed Phase 1 study of Recurrent Adult Acute Myeloid Leukemia and Granulocytic Sarcoma, sponsored by Wake Forest University Health Sciences.

NCT02484391 is a Phase 1 study of Recurrent Adult Acute Myeloid Leukemia and Granulocytic Sarcoma that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 48 participants, roughly in line with the 52-participant average among 19 other Recurrent Adult Acute Myeloid Leukemia trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02484391, a Phase 1 study of Recurrent Adult Acute Myeloid Leukemia and Granulocytic Sarcoma, has completed, sponsored by Wake Forest University Health Sciences.

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

Study Summary

This pilot phase I trial studies how well CPI-613 (6,8-bis\[benzylthio\]octanoic acid), cytarabine, and mitoxantrone hydrochloride work in treating patients with acute myeloid leukemia or granulocytic sarcoma (a malignant, green-colored tumor of myeloid cells \[a type of immature white blood cell\]) that has returned (relapsed) or that does not respond to treatment (refractory). 6,8-bis(benzylthio)octanoic acid is thought to kill cancer cells by turning off their mitochondria. Mitochondria are used by cancer cells to produce energy and are the building blocks needed to make more cancer cells. By shutting off these mitochondria, 6,8-bis(benzylthio)octanoic acid deprives the cancer cells of energy and other supplies that they need to survive and grow in the body. Drugs used in chemotherapy, such as cytarabine and mitoxantrone hydrochloride, 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 6,8-bis(benzylthio)octanoic acid together with cytarabine and mitoxantrone hydrochloride may kill more cancer cells.

Primary Outcome

Feasibility is determined by the percentage of patients eligible for maintenance therapy who complete at least 3 cycles, if ≥50% of eligible patients complete 3 cycles of maintenance therapy we will consider this regimen feasible for future study.

Conditions Studied

Recurrent Adult Acute Myeloid Leukemia Granulocytic Sarcoma

Interventions

  • DRUG Cytarabine
  • PROCEDURE Hematopoietic Cell Transplantation
  • DRUG 6,8-Bis(benzylthio)octanoic Acid
  • DRUG Mitoxantrone Hydrochloride

Study Locations (1)

North Carolina

  • Comprehensive Cancer Center of Wake Forest University - Winston-Salem

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2015-09
Est. Completion 2022-02-02
Phase Phase 1
Wake Forest University Health Sciences

1,140 total trials

What the finished NCT02484391 record still lists

NCT02484391 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, roughly in line with the 52-participant average among 19 other Recurrent Adult Acute Myeloid Leukemia trials with a reported enrollment target.

The record links to 2 conditions, with Recurrent Adult Acute Myeloid Leukemia appearing as the primary indexed condition, and to 4 interventions - of which Cytarabine is the first listed.

NCT02484391 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT02484391 about?

NCT02484391 is a clinical study titled "CPI-613, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Granulocytic Sarcoma". This pilot phase I trial studies how well CPI-613 (6,8-bis\[benzylthio\]octanoic acid), cytarabine, and mitoxantrone hydrochloride work in treating patients with acute myeloid leukemia or granulocytic sarcoma (a malignant, green-colored tumor of myeloid cells \[a type of immature white blood cell\])...

What is the current status of trial NCT02484391?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2015-09. Estimated completion is 2022-02-02.

What conditions does trial NCT02484391 study?

This clinical trial studies the following conditions: Recurrent Adult Acute Myeloid Leukemia, Granulocytic Sarcoma.

What interventions are being tested in trial NCT02484391?

The interventions under investigation include: Cytarabine (DRUG), Hematopoietic Cell Transplantation (PROCEDURE), 6,8-Bis(benzylthio)octanoic Acid (DRUG), Mitoxantrone Hydrochloride (DRUG).

Who is sponsoring clinical trial NCT02484391?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02484391 being conducted?

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

Learn More About Clinical Trials

Similar trials for Recurrent Adult Acute Myeloid Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02484391's enrollment target sits among peer trials

48 6th of 19 higher than 14 of 19 other Recurrent Adult Acute Myeloid Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Recurrent Adult Acute Myeloid Leukemia 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 NCT02484391, the US trial registry maintained by the National Library of Medicine. NCT02484391 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.