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Horse ATG in Patients With AA or Low/Int-1 Risk MDS

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leukemia

Intervention: hATG (Drug); Cyclosporine (Drug); Methylprednisone (Drug); Pegfilgrastim (Drug); Filgrastim (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Tapan Kadia, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

Overall contact:
Tapan Kadia, MD, Phone: 713-563-3534

Summary

The goal of this clinical research study is to learn if horse anti-thymocyte globulin (hATG), given in combination with methylprednisolone, cyclosporine, and G-CSF (filgrastim or pegfilgrastim), can help to control AA and/or low-int-1 risk MDS. The safety of this drug combination will also be studied. hATG is made from horse blood and targets immune cells known as T-lymphocytes. Since T-lymphocytes are believed to be involved in causing low blood counts in AA and in some cases of MDS, killing these cells may help treat the disease. Methylprednisolone and cyclosporine work to suppress immune cells called lymphocytes. This may help to improve low blood counts in AA and in some cases of MDS. Filgrastim and pegfilgrastim are designed to cause white blood cells to grow. This may help to fight infections and help improve the white blood cell count.

Clinical Details

Official title: Phase II Study of Horse Anti-Thymocyte Globulin (hATG), Cyclosporine, Methylprednisone, and GCSF (Filgrastim or Pegfilgrastim) in Patients With Aplastic Anemia (AA), or Low/Int-1 Risk Myelodysplastic Syndrome (MDS)

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Achievement of Response

Secondary outcome: Time to Response

Detailed description: Study Drug Administration: If you are found to be eligible to take part in this study, you will be admitted to the hospital. On the first day, before starting the hATG, a small amount of diluted hATG will be injected under your skin to make sure that you are not allergic to it. If you have a reaction, more testing may be done. If the reaction is severe, you will be taken off study. On Days 1-4 you will receive methylprednisolone by vein over about 10 minutes. You will receive hATG by vein over 8 hours. If you are able to tolerate ATG without any significant side effects, you should be out of the hospital in about 4-5 days. On Days 1-180 you will take cyclosporine by mouth 2 times a day at about the same time every day. On Day 5 (or starting on Day 5) you will receive filgrastim or pegfilgrastim by an injection under your skin. Your doctor will decide which drug you will receive. If you receive pegfilgrastim, you will receive it one time on Day 5. If you receive filgrastim, you will receive it starting on Day 5. You will continue to receive it until your blood counts recover. You will be given standard drugs to help decrease the risk of side effects. You may be given a drug called eltrombopag to help increase your platelet counts if you have low platelets or complications related to low platelets. You may ask the study staff for information about how the drugs are given and their risks. Study Visits: One time weekly for the first 4-6 weeks and then 1 time a month during Months 2-6

- Your complete medical history will be recorded.

- You will have a physical exam, including measurement of your height, weight, and vital

signs (blood pressure, heart rate, breathing rate, and temperature).

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

At the end of Month 3 and then when the doctor thinks it is needed, you will have a bone marrow aspirate/biopsy to check the status of the disease. Length of Treatment: You may continue taking the study drug for up to 6 months. 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 once you have completed the follow-up visits. Follow-Up Visits: When you are off treatment, every 6-12 months you will be called by a member of the study staff. You will be asked about any side effects you may be having. The phone calls will take about 5-10 minutes. This is an investigational study. hATG, cyclosporine, methylprednisolone, and filgrastim/pegfilgrastim are all FDA approved and commercially available for use in patients with AA and MDS. The use of filgrastim/pegfilgrastim with this drug combination is investigational. Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Patients with the diagnosis of MDS (Low, Int-1 by IPSS, or hypocellular) who are either previously treated or untreated are eligible for this trial. 2. Patients with the diagnosis of aplastic anemia who are either previously treated or untreated are eligible if they are not currently candidates for an allogeneic stem cell transplant. 3. All ages are eligible. 4. Patients must have been off of cytotoxic, immunosuppressive (except steroids), or targeted therapy for at least 2 weeks prior to entering this study, and have recovered from the toxic effects of that therapy to grade 1 or less. 5. Adequate organ function as defined as: liver function (bilirubin < 2mg/dL, AST <3 x ULN), kidney function (creatinine < 2. 5 x ULN ). 6. ECOG performance status of

Locations and Contacts

Tapan Kadia, MD, Phone: 713-563-3534

University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting
Additional Information

University of Texas MD Anderson Cancer Center Website

Starting date: June 2012
Last updated: March 12, 2015

Page last updated: August 23, 2015

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