Study of MLN9708 as Maintenance Therapy for Patients With Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS) in Remission

Leukemia Clinical Trial

Official title: Phase II Study Of Ixazomib As Maintenance Therapy For Patients With Acute Myeloid Leukemia (AML) And High Risk Myelodysplastic Syndrome (MDS) In Remission

Status Terminated

Clinical Trial Summary

The goal of this clinical research study is to learn if ixazomib can prevent AML or MDS from coming back in patients who are in remission. The safety of this drug will also be studied.

Clinical Trial Description

Study Drug Administration:

Each study cycle is 28 days.

If you are found to be eligible to take part in this study, you will take ixazomib capsules on Days 1, 8 and 15 of each cycle. Ixazomib capsules should be swallowed whole, with water, on an empty stomach (take the dose at least 1 hour before or 2 hours after a meal).

If you miss a dose, take it as soon as you remember, as long as the next scheduled dose is more than 3 days away. If you vomit after taking a dose, do not make up the dose but continue with the next scheduled dose as planned.

You may receive the study drug for up to 12 cycles. If the doctor thinks it is in your best interest, you may be able to continue taking the study drug beyond Cycle 12.

Study Visits:

On Day 1 of each cycle (+/- 1 day):

• You will have a physical exam.

• Blood (about 2-3 teaspoons) will be drawn for routine tests.

On Days 8 and 15 of Cycle 1, blood (about 2-3 teaspoons) will be drawn for routine tests.

Every third cycle, you will have a bone marrow aspiration and/or biopsy to check the status of the disease.

Length of Study:

You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over after the end-of-study visit.

End-of-Study Visit:

After your last dose of study drug, you will return to the clinic for an end-of-study visit.

• Blood (about 2-3 tablespoons) will be drawn for routine tests.

• You will have a bone marrow aspirate and/or biopsy to check the status of the disease.

This is an investigational study. Ixazomib is not FDA-approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work.

Up to 40 participants will be enrolled in this study. All will take part at MD Anderson. ;

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Preleukemia

• NCT number: NCT02302846
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Terminated
• Phase: Phase 2
• Start date: March 20, 2015
• Completion date: May 30, 2017