NCT02484391 is a Phase 1 clinical trial of 6,8-Bis(benzylthio)octanoic Acid in Granulocytic Sarcoma, sponsored by Wake Forest University Health Sciences.

Who is sponsoring NCT02484391?

NCT02484391 is sponsored by Wake Forest University Health Sciences.

What drugs are being tested in NCT02484391?

Interventions in NCT02484391: 6,8-Bis(benzylthio)octanoic Acid, Cytarabine, Hematopoietic Cell Transplantation, Mitoxantrone Hydrochloride.

What condition does NCT02484391 study?

NCT02484391 studies Granulocytic Sarcoma, Recurrent Adult Acute Myeloid Leukemia.

Is NCT02484391 still recruiting?

NCT02484391 is currently completed. Last updated 20 August 2024.

Are results published for NCT02484391?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-08-20 · How we verify

NCT02484391

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

An Open Label Study to Evaluate the Feasibility of CPI-613 Given With High Dose Cytarabine and Mitoxantrone in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Completed Phase 1 Results posted Last updated 20 August 2024

What this trial tests

Phase 1 trial testing 6,8-Bis(benzylthio)octanoic Acid in Granulocytic Sarcoma in 48 participants. Completed in 2 February 2022.

Timeline

1 September 2015

Primary endpoint
1 October 2018

2 February 2022

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	1 September 2015
Primary completion	1 October 2018
Estimated completion	2 February 2022
Sites	1 location across United States

Drugs / interventions tested

6,8-Bis(benzylthio)octanoic Acid — full drug profile →
Cytarabine — full drug profile →
Hematopoietic Cell Transplantation — full drug profile →
Mitoxantrone Hydrochloride — full drug profile →

Conditions studied

Granulocytic Sarcoma — all drugs for Granulocytic Sarcoma →
Recurrent Adult Acute Myeloid Leukemia — all drugs for Recurrent Adult Acute Myeloid Leukemia →

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, any sex, with Granulocytic Sarcoma or Recurrent Adult Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Feasibility of Administering CPI-613 in Combination With High Dose Cytarabine and Mitoxantrone During Induction, Consolidation and Maintenance Therapies, Defined as Percentage of Patients Eligible for Maintenance Therapy Who Complete at Least 3 Courses
Time frame: Up to 12 weeks of maintenance therapy
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.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02484391 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Wake Forest University Health Sciences
Last refreshed: 20 August 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02484391.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing