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

2016-02-17 22:08:22 | BioPortfolio

Summary

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.

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.

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.

Study Visits:

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Leukemia

Intervention

SGI-110, Donor Lymphocyte Infusion

Location

University of Texas MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Not yet recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-02-17T22:08:22-0500

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Medical and Biotech [MESH] Definitions

The transfer of lymphocytes from a donor to a recipient or reinfusion to the donor.

Transfer of GASTROINTESTINAL MICROBIOTA from one individual to another by infusion of donor FECES to the upper or lower GASTROINTESTINAL TRACT of the recipient.

Endogenous superantigens responsible for inducing strong proliferative responses in T-cells in mixed lymphocyte reactions (see LYMPHOCYTE CULTURE TEST, MIXED). They are encoded by mouse mammary tumor viruses that have integrated into the germ line as DNA proviruses (MINOR LYMPHOCYTE STIMULATORY LOCI).

A replication-defective strain of Murine leukemia virus (LEUKEMIA VIRUS, MURINE) capable of transforming lymphoid cells and producing a rapidly progressing lymphoid leukemia after superinfection with FRIEND MURINE LEUKEMIA VIRUS; MOLONEY MURINE LEUKEMIA VIRUS; or RAUSCHER VIRUS.

Use of any infusion therapy on an ambulatory, outpatient, or other non-institutionalized basis.

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