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The goal of this clinical research study is to learn if giving donor lymphocyte cells and SGI-110 will help control AML and MDS. The safety of this treatment will also be studied.
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.
If the doctor thinks it is needed, your dose of SGI-110 may be changed or stopped during the study.
On Day 6 of Cycles 2, 4, and 6, you will receive a donor lymphocyte infusion by vein over about 10-30 minutes.
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.
About 1-3 days before the start of each cycle and then one time during Weeks 1, 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 1 of Cycles 1 and 2, blood (about 1 teaspoon) will be drawn for pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points.
On Day 28 of Cycles 1, 2, and 4:
- 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marrow aspiration/biopsy, an area of the hip is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.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.
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 50 participants will take part in this study. All will be enrolled at MD Anderson.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
SGI-110, Donor Lymphocyte Infusion
University of Texas MD Anderson Cancer Center
Not yet recruiting
M.D. Anderson Cancer Center
Published on BioPortfolio: 2016-02-17T22:08:22-0500
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Use of any infusion therapy on an ambulatory, outpatient, or other non-institutionalized basis.
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