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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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2015-09 |
| Est. Completion | 2022-02-02 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02484391
The ClinicalTrials.gov registry entry for NCT02484391 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 52-participant average among 19 other Recurrent Adult Acute Myeloid Leukemia trials with a reported enrollment target. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Recurrent Adult Acute Myeloid Leukemia
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