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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02484391
Other study ID # IRB00033779
Secondary ID NCI-2015-01002IR
Status Completed
Phase Phase 1
First received
Last updated
Start date September 2015
Est. completion date February 2, 2022

Study information

Verified date August 2023
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
6,8-Bis(benzylthio)octanoic Acid
Given IV
Cytarabine
Given IV
Procedure:
Hematopoietic Cell Transplantation
Undergo stem cell transplant
Drug:
Mitoxantrone Hydrochloride
Given IV

Locations

Country Name City State
United States Comprehensive Cancer Center of Wake Forest University Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Wake Forest University Health Sciences National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Early mortality (death within 60 days of beginning of treatment) to the observed rates in a historical cohort of subjects Will use a one-sided exact test for a single proportion, a 0.05 significance level. Up to 60 days
Other Complete response Complete response will be compared to the observed rates in a historical cohort of subjects (CCCWFU 22111). Will use a one-sided exact test for a single proportion, a 0.05 significance level. Up to 3 years
Primary 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 Up to 12 weeks of maintenance therapy
Secondary Frequency of toxicities experienced by the participants, graded using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0 The frequency of toxicities experienced by the participants will be presented by type and grade in an effort to monitor and report safety of the treatment. Up to 3 years
Secondary Overall survival Will use Kaplan-Meier estimation to analyze overall survival. Time from enrollment on trial to death from any cause, assessed up to 6 months after completion of therapy
Secondary Response rate (CR and CRi), assessed by standard criteria for AML Confidence intervals will be calculated around the estimates of the response rate (CR and CRi). Assuming a response rate of 0.5, with 50 participants, 95 percent confidence intervals can be created with a 0.14 margin of error (0.36, 0.64). Up to 3 years
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