A Leukemia SPORE Phase II Clinical Trial Comparing Decitabine Versus Decitabine/Carboplatin and Decitabine/Arsenic for the Treatment of Relapsed, Refractory, and Elderly Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

Leukemia Clinical Trial

Official title: Leukemia SPORE Phase II Randomized Study of Decitabine Versus Decitabine and Carboplatin Versus Decitabine and Arsenic in Relapsed, Refractory and Elderly Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

Status Active, not recruiting

Clinical Trial Summary

The goal of this clinical research study is to compare the response rates of patients receiving decitabine alone, decitabine with carboplatin, and decitabine with arsenic trioxide in patients with AML or MDS.

Clinical Trial Description

Study Groups:

If you are found to be eligible to take part in this study and you are one of the first 30 participants enrolled, you will have an equal chance of being in one of 3 study groups. If you enroll after the first 30 participants are enrolled, you will have a higher chance of being assigned to the group is having better results.

• If you are in Group 1, you will receive decitabine alone.

• If you are in Group 2, you will receive decitabine and carboplatin.

• If you are in Group 3, you will receive decitabine and arsenic trioxide.

Study Drug Administration:

Every 4 weeks is a study cycle.

You will receive decitabine by vein over about 1 hours on Days 1-5 of each cycle.

If you are receiving carboplatin, you will receive it over 1 hour on Day 8 (+/-2 days) of each cycle.

If you are receiving arsenic trioxide, you will receive it over about 1 hour on Days 1-5 of each cycle

Study Visits:

Blood (about 1-2 teaspoons) will be drawn 1-2 times a week during Cycle 1 and then every 2-4 weeks after that for routine tests. If you have stable disease, blood will only be drawn every 4-6 weeks.

On Day 28 of Cycle 3 (+/- 3 days), you will have a bone marrow aspirate and biopsy to check the status of the disease. After that, you will have bone marrow biopsies/aspirations when the doctor thinks it is needed.

If you are in Group 3, you will have EKGs on Day 1 of each cycle before receiving the study drugs. On Days 1 and 4 of each cycle, blood (about 1-2 teaspoons) will also be drawn for routine tests before your dose of the study drugs.

If you are taken off study, blood (about 1-2 teaspoons) will be drawn for routine tests.

Length of Study:

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

This is an investigational study. Arsenic trioxide is FDA approved and commercially available for the treatment of APL. Decitabine is FDA approved and commercially available for the treatment of MDS. Carboplatin is FDA approved and commercially available for the treatment solid tumors. The study drug or study drug combination you receive on this study are considered investigational.

Up to 120 patients will take part in this study. Up to 20 patients will be enrolled at MD Anderson. ;

Related Conditions & MeSH terms

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

• NCT number: NCT02188706
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 2014
• Completion date: July 2026