6,8-Bis(Benzylthio)Octanoic Acid, Cytarabine, and Daunorubicin Hydrochloride in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Untreated Adult Acute Myeloid Leukemia Clinical Trial

Official title: A Phase I/II Study of CPI-613 in Combination With Induction/Consolidation in Older AML Patients

Status Withdrawn

Clinical Trial Summary

This phase I/II trial studies the side effects and the best dose of 6,8-bis(benzylthio)octanoic acid (CPI-613) when given together with cytarabine and daunorubicin hydrochloride and to see how well it works in treating older patients with newly diagnosed acute myeloid leukemia. CPI-613 may kill tumor cells by turning off mitochondria (small structures in the cancer cells that are found in the cytoplasm [fluid that surrounds the cell nucleus]). Mitochondria are used by cancer cells to produce energy and are the building blocks needed to make more tumor cells. By shutting off mitochondria, CPI-613 may deprive the cancer cells of energy and other supplies that they need to survive and grow. Drugs used in chemotherapy, such as cytarabine and daunorubicin 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 CPI-613 together with cytarabine and daunorubicin hydrochloride may kill more cancer cells.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD). (Phase I) II. To determine treatment response with the addition of CPI-613 to induction therapy in patients with newly diagnosed acute myeloid leukemia (AML). (Phase II)

SECONDARY OBJECTIVES:

I. To assess the safety of administering CPI-613 under the proposed study regimen. (Phase I/II) II. To assess survival endpoints of patients receiving the proposed study regimen. (Phase II) III. To assess the rate of allogeneic stem cell transplantation. (Phase II)

OUTLINE: This is a phase I, dose-escalation study of 6,8-bis(benzylthio)octanoic acid followed by a phase II study.

INDUCTION: Patients receive cytarabine intravenously (IV) continuously on days 1-7, daunorubicin hydrochloride IV on days 1-3, and 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 3-7. Patients then undergo biopsy on day 14. Patients experiencing significant residual disease receive cytarabine IV continuously on days 1-5, daunorubicin hydrochloride IV on days 1-2, and 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5.

CONSOLIDATION: Beginning 42 days later, patients receive cytarabine IV continuously on days 1-16 and 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 2-6. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients not undergoing transplant after consolidation receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 14 days and then every 3 months for 2 years. ;

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Untreated Adult Acute Myeloid Leukemia

• NCT number: NCT02472626
• Study type: Interventional
• Source: Wake Forest University Health Sciences
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: December 2015
• Completion date: July 2016