Horse ATG in Patients With Aplastic Anemia (AA) or Low/Int-1 Risk Myelodysplastic Syndrome (MDS)
Status: | Recruiting |
---|---|
Conditions: | Blood Cancer, Anemia, Leukemia |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 10/26/2018 |
Start Date: | June 2012 |
End Date: | June 2019 |
Contact: | Tapan Kadia, MD |
Phone: | 713-563-3534 |
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)
If you are reading and signing this form on behalf of a potential participant, please note:
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential
participant.
You are being asked to take part in this study because you have aplastic anemia (AA) or
low/int-1 risk myelodysplastic syndrome (MDS).
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-sndz 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-sndz 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.
This is an investigational study. hATG, cyclosporine, methylprednisolone, and
filgrastim-sndz/pegfilgrastim are all FDA approved and commercially available for use in
patients with AA and MDS. The use of filgrastim-sndz/pegfilgrastim with this drug combination
is investigational.
Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential
participant.
You are being asked to take part in this study because you have aplastic anemia (AA) or
low/int-1 risk myelodysplastic syndrome (MDS).
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-sndz 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-sndz 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.
This is an investigational study. hATG, cyclosporine, methylprednisolone, and
filgrastim-sndz/pegfilgrastim are all FDA approved and commercially available for use in
patients with AA and MDS. The use of filgrastim-sndz/pegfilgrastim with this drug combination
is investigational.
Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.
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 = 2.
7. Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and for
the duration of study participation. Should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her treating physician
immediately.
8. A negative urine pregnancy test is required within 1 week for all women of
childbearing potential prior to enrolling on this trial.
9. Patient must have the ability to understand the requirements of the study and signed
informed consent. A signed informed consent by the patient or his legally authorized
representative is required prior to their enrollment on the protocol.
10. Patients should have an indication for therapy for their disease such as transfusion
dependence or morbidity associated with their cytopenia(s) such as bleeding, severe
fatigue, or frequent/multiple infections (eg. neutropenia).
Exclusion Criteria:
1. Pregnant women are excluded from this study. Because there is an unknown but potential
risk for adverse events in nursing infants secondary to treatment of the mother with
the study agents, breastfeeding should be discontinued if the mother is treated on
this study.
2. Known HIV infection
3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.
4. Patient with documented hypersensitivity to any of the component medications.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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