NCT03634228

Milademetan Tosylate and Low-Dose Cytarabine With or Without Venetoclax in Treating Participants With Recurrent or Refractory Acute Myeloid Leukemia

A Phase I/II Study of the Oral MDM2 Inhibitor DS-3032b (Milademetan) in Combination With Low Dose Cytarabine (LDAC) in Patients With Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia (AML)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial studies the side effects and best dose of milademetan tosylate and to see how well it works with cytarabine with or without ventoclax in treating participants with acute myeloid leukemia that has come back (recurrent) or that does not respond to treatment (refractory). Milademetan tosylate and ventoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine, 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. It is not yet known if giving milademetan tosylate and low-dose cytarabine with or without ventoclax will work better in treating participants with recurrent or refractory acute myeloid leukemia.

Detailed description

If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. If you are enrolled in Phase 1, the dose of DS-3032b you receive will depend on when you join this study. If you are enrolled in Phase 2, you will receive DS-3032b at the highest dose that was tolerated in Phase 1. All participants will receive LDAC at a fixed dose (meaning the dose will not change). If you are assigned to receive it, your dose of venetoclax will not change either. However, if needed because you have side effects, your dose may be adjusted. Up to 58 participants will be enrolled in this study. All will take part at MD Anderson.

Conditions

• Acute Myeloid Leukemia
• Recurrent Acute Myeloid Leukemia
• Refractory Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Cytarabine	Given SC
DRUG	Milademetan Tosylate	Given PO
DRUG	Venetoclax	Given PO

Timeline

• Start date: 2018-12-17
• Primary completion: 2022-04-03
• Completion: 2022-04-03
• First posted: 2018-08-16
• Last updated: 2023-06-15
• Results posted: 2023-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study