Last updated on November 2018

SGI-110 With Donor Lymphocyte Infusion (DLI) for Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS) Relapsing Post Allogeneic Stem Cell Transplantation (AlloSCT)

Brief description of study

The goal of this clinical research study is to learn if giving donor lymphocyte cells and SGI-110 will help control acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) (including Chronic Myelomonocytic Leukemia [CMML]) in patients who have had an allogeneic stem cell transplant (using someone else's stem cells) and have relapsed (the disease has gotten worse). Researchers also want to find out if giving SGI-110 after allogenic stem cell transplant in high risk AML and MDS patients would help to improve how long they may remain in remission (free of disease) after transplant.

Researchers also want to learn if SGI-110, when given as maintenance therapy for high-risk AML and MDS patients, will reduce the risk of relapse after an allogenic stem cell transplantation.

The safety of this treatment will also be studied.

This is an investigational study. SGI-110 is not FDA approved or commercially available. SGI-110 is made with decitabine, which is FDA approved and commercially available to treat MDS. SGI-110 is currently being used for research purposes only. The use of donor lymphocytes to treat MDS and AML is FDA approved.

Up to 90 participants will take part in this study. All will be enrolled at MD Anderson.

Detailed Study Description

Study Treatment Administration:

If you are found to be eligible to take part in this study, you will receive SGI-110 as an injection under the skin 1 time a day on Days 1-5 of each 28-day cycle. Day 1 is the first day you will receive the study drug. You may receive up to 12 cycles of SGI-110.

The study doctor will tell you how long each of your cycles may be and when your next cycle will start.

If the doctor thinks it is needed, your dose of SGI-110 may be changed or stopped during the study.

Donor Lymphocyte Infusions:

On Day 6 of Cycles 2, 4, and 6, you will receive a donor lymphocyte infusion by vein over about 10-30 minutes. If you have high-risk AML or MDS and you are receiving SGI-110 as maintenance, you will not receive donor lymphocyte infusions.

Graft-versus-host disease (GVHD) may occur after the T-cell infusion. GVHD occurs when donor cells attack the cells of the person receiving the stem cell transplant. If GVHD occurs, you will be given standard drugs that may help control GVHD. You may ask the study staff for information about how the drugs are given and their risks. You cannot continue to receive the study drug until the GVHD is controlled. The study doctor will discuss this with you.

Study Visits:

Within 3 days before the start of each cycle, on Day 3 of each cycle, and then one time during Weeks 2 and 3 of each cycle (if the doctor thinks it is needed), blood (about 2 tablespoons) will be drawn for routine tests and to check your kidney and liver function. Part of this blood sample will be used for a pregnancy test if you can become pregnant. Urine may also be collected for this pregnancy test.

You may be able to have these blood draws performed at a local lab or clinic closer to your home. The results of these tests will be sent to the study doctor at MD Anderson for review. Talk with the study doctor about this possibility.

On Day 28 of Cycles 1, 2, 4, and 6 or on Day 100 and then at 6 months and 1 year after the stem cell transplant (if you have high-risk AML or MDS):

  • Blood (about 2 tablespoons) will be drawn for chimerism studies, which looks to see how much the blood cells mixed between the donor and recipient. This test shows how well the lymphocyte infusion has "taken."
  • If the doctor thinks it is needed, you may have a bone marrow aspiration and biopsy performed to check the status of the disease. To collect a bone marrow aspiration/biopsy, an area of the hip is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.

These tests/procedures may be performed more often, if you doctor thinks it is needed.

Length of Treatment:

You may receive up to 12 cycles of SGI-110. You may be taken off study early if the disease gets worse, if intolerable side effects occur, if you develop uncontrolled or severe GVHD, or if your doctor thinks it is in your best interest.

Clinical Study Identifier: NCT02684162

Contact Investigators or Research Sites near you

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Betul Oran, MD

University of Texas MD Anderson Cancer Center
Houston, TX United States
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