The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low Risk Myelodysplastic Syndrome (MDS)



Status:Active, not recruiting
Conditions:Cancer, Blood Cancer, Anemia, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:1/13/2019
Start Date:April 26, 2013
End Date:August 31, 2021

Use our guide to learn which trials are right for you!

A Phase 3, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Subjects With Red Blood Cell Transfusion-dependent Anemia and Thrombocytopenia Due to IPSS Lower-risk Myelodysplastic Syndromes.

Evaluation of the Efficacy and Safety of Oral Azacitidine plus Best Supportive care versus
Placebo and Best Supportive care in subjects with red blood cell (RBC) transfusion-dependent
anemia and thrombocytopenia due to International Prognostic Scoring System (IPSS) lower risk
myelodysplastic syndromes (MDS).


Inclusion Criteria:

- 18 years or older

- Have a documented diagnosis of MDS

- Anemia that requires red blood cell transfusions

- Thrombocytopenia (sustained for at least 21 days) within 14 days prior to
randomization

- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

- Must agree to follow pregnancy precautions as required by protocol.

- Understand and voluntarily sign an informed consent document prior to any study
related assessments/procedures being conducted

Exclusion Criteria:

- Secondary or hypoplastic MDS or other subtype with eligibility for treatment with
immunotherapy

- Prior treatment with azacitidine, decitabine, other hypomethylating agents and
lenalidomide ( for lenalidomide : unless the last dose received is >= 8 weeks prior to
inclusion into the study).

- Prior allogeneic or autologous stem cell transplant

- Eligible for allogenic or autologous stem cell transplant

- History of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis),
celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other
gastrointestinal disorder or defect

- Thrombocytopenia secondary to other possible causes, including medication(s),
congenital disorder(s), immune disorder(s), or microvascular disorder(s)

- Use of cytotoxic, chemotherapeutic, targeted or investigational agents/therapies,
thrombopoiesis-stimulating agents (TSAs), erythropoiesis-stimulating agents (ESAs) and
other red blood cell hematopoietic growth factors, and within 28 days prior to
randomization

- Ongoing medically significant adverse events from previous treatment, regardless of
the time period

- Concurrent use of iron-chelating agents, (except for subjects on a stable or
decreasing dose for at least 8 weeks (56 days) prior to randomization), corticosteroid
(except for subjects on a stable or decreasing dose for ≥ 1 week prior to
randomization for medical conditions other than MDS)

- Prior history of cancer, other than MDS, unless the subject has been free of the
disease for ≥ 3 years. (Basal or squamous cell carcinoma of the skin, carcinoma in
situ of the cervix, carcinoma in situ of the breast, and incidental histologic finding
of prostate cancer) (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical
staging system is allowed)

- Significant active cardiac disease within the previous 6 months

- Uncontrolled systemic fungal, bacterial, or viral infection

- Known Human Immunodeficiency Virus (HIV) or Hepatitis C (HCV) infection, or evidence
of active Hepatitis B Virus (HBV) infection

- Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies,
or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding

- Abnormal coagulation parameters

- Abnormal liver function test results

- Abnormal kidney function test results

- Known or suspected hypersensitivity to azacitidine or mannitol

- Any significant medical condition, laboratory abnormality, or psychiatric illness
We found this trial at
40
sites
Metairie, Louisiana 70006
?
mi
from
Metairie, LA
Click here to add this to my saved trials
1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Albany, GA
Click here to add this to my saved trials
Baltimore, Maryland 21231
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Berkeley, California 94704
?
mi
from
Berkeley, CA
Click here to add this to my saved trials
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Charlotte, North Carolina 28211
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
2035 W Taylor St
Chicago, Illinois
(312) 996-4350
University of Illinois at Chicago A major research university in the heart of one of...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Duarte, California 91010
?
mi
from
Duarte, CA
Click here to add this to my saved trials
?
mi
from
Escondido, CA
Click here to add this to my saved trials
3551 Roger Brooke Drive
Fort Sam Houston, Texas 78235
?
mi
from
Fort Sam Houston, TX
Click here to add this to my saved trials
Greenbrae, California 94904
?
mi
from
Greenbrae, CA
Click here to add this to my saved trials
Greenville, North Carolina 27834
?
mi
from
Greenville, NC
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77090
?
mi
from
Houston, TX
Click here to add this to my saved trials
Jackson, Mississippi 39202
?
mi
from
Jackson, MS
Click here to add this to my saved trials
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
4321 Washington Street #4000
Kansas City, Missouri 64111
(816) 932-3300
Saint Luke's Cancer Institute Hope is an important part of the arsenal that helps patients...
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
La Jolla, California 92037
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Maywood, Illinois 60153
?
mi
from
Maywood, IL
Click here to add this to my saved trials
333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
1 Gustave L. Levy Place
New York, New York 10029
?
mi
from
New York, NY
Click here to add this to my saved trials
Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
?
mi
from
Omaha, NE
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15224
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Waukesha, Wisconsin 53188
?
mi
from
Waukesha, WI
Click here to add this to my saved trials
Worcester, Massachusetts 01655
?
mi
from
Worcester, MA
Click here to add this to my saved trials