Status:
TERMINATED
A Study Comparing Siltuximab Plus Best Supportive Care to Placebo Plus Best Supportive Care in Anemic Patients With International Prognostic Scoring System Low- or Intermediate-1-Risk Myelodysplastic Syndrome
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy of siltuximab, demonstrated by a reduction in red blood cell (RBC), transfusions to treat the anemia of Myelodysplastic Syndrome (MDS).
Detailed Description
The study treatments will be administered double-blind for 12 weeks, meaning that the patient and study personnel will not know the identity of the treatment. Approximately 75 patients will be randomi...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of myelodysplastic syndrome (MDS), according to World Heath Organization or the French-American-British Cooperative Group pathologic classification, with an International Prognostic Scoring System score 0, 0.5, or 1.0, indicating Low- or INT-1-risk disease.
- Documented RBC transfusion of at least 2 units of RBC for the treatment of the anemia of MDS in the 8 weeks preceding the start of the Screening Period.
- Adequate iron stores, demonstrated by either the presence of stainable iron in the bone marrow or a serum ferritin of \> 100 ng/mL.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
- Symptomatic anemia (defined by a score \> 0 on the Non-Chemotherapy Anemia Symptom Scale \[NCA-SS\]).
Exclusion
- Had treatment with drugs or other agents targeting IL-6 or its receptor within 4 weeks of randomization.
- Any condition that, in the opinion of the investigator, would make participation not in the best interest (eg, compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments.
- Patients with Chronic Myelomonocytic Leukemia (CMML).
- Causes other than MDS contributing to anemia, such as Vitamin B12 or folate deficiency, bleeding, hemolysis, hemoglobinopathy, or chronic renal failure.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01513317
Start Date
November 1 2011
End Date
September 1 2012
Last Update
September 29 2014
Active Locations (23)
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1
Tampa, Florida, United States
2
Boston, Massachusetts, United States
3
New York, New York, United States
4
Winston-Salem, North Carolina, United States