The DACOGEN Difference in a Phase III Trial
Baseline Patient Characteristics (Intent-to-Treat Population)1,2
Many patients had complex risk factors at baseline. The ITT population for DACOGEN included those patients with:
- 45% IPSS Intermediate or poor cytogenetics
- 74% red blood cell dependent
- 13% secondary MDS
- 30% previously treated with MDS therapy
The Trial Design
A randomized open-label, multicenter, controlled trial evaluated 170 adult patients
with myelodysplastic syndromes (MDS) meeting French-American-British (FAB) classification
criteria and International Prognostic Scoring System (IPSS) High-risk, Intermediate-2
and Intermediate-1prognostic scores. Eighty-nine patients were randomized to DACOGEN
therapy plus supportive care (only 83 received DACOGEN)*, and 81 to Supportive Care
(SC) alone. Patients with Acute Myeloid Leukemia (AML) were not intended to be included.
Of the 170 patients included in the study, independent review (adjudicated diagnosis)
found that 12 patients (9 in the DACOGEN arm and 3 in the SC arm) had the diagnosis
of AML at baseline.1
Response Criteria
DACOGEN was proven to meet stringent International Working Group (IWG) 2000 response criteria (Table 1).12,9
Response duration was defined as 8 weeks.
Table 1. IWG 2000 Response Criteria† for MDS1
† Responses were adjudicated by a blinded, centralized, expert
review of bone marrow aspirates.
Read about the DACOGEN Phase III trial or watch the DACOGEN Clinical Trials Video.
IMPORTANT SAFETY INFORMATION
DACOGEN may cause fetal harm when administered to a pregnant woman. Women of childbearing
potential should be advised to avoid becoming pregnant while using DACOGEN. Men
should be advised not to father a child while receiving treatment with DACOGEN,
and for 2 months afterwards. The most commonly occurring adverse reactions include
neutropenia, thrombocytopenia, anemia, pyrexia, fatigue, nausea, cough, petechiae,
constipation, diarrhea, and hyperglycemia.
DACOGEN is available by prescription only. Please see the important product information
for DACOGEN for more information. This site does not contain everything that is
known about DACOGEN. If you would like to know more, talk to your healthcare professional.
This web site contains information relating to various medical conditions and their
treatment. Such information is provided for educational purposes only and is not
meant to be a substitute for the advice of a physician or other health care professional.
You should not use this information for diagnosing a health problem or disease.
Individual responses to DACOGEN treatment may vary.
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