To Demonstrate Superiority of Decitabine Over Azacitidine in Subjects With Intermediate- or High-risk MDS.

Myelodysplastic Syndromes Clinical Trial

Official title:

A Randomized, Open-label, Parallel-Group Study Comparing the Efficacy and Safety of DACOGEN (Decitabine) for Injection and VIDAZA (Azacitidine) for Injection In Subjects With Intermediate or High Risk Myelodysplastic Syndromes (MDS)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01011283
• Other study ID #: E7373-A001-401
• Status: Terminated
• Phase: Phase 4
• First received: November 5, 2009
• Last updated: October 21, 2014
• Start date: November 2009

Study information

• Verified date: October 2014
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the response of patients with Intermediate or High Risk myelodysplastic syndromes (MDS) following treatment with decitabine or azacitidine.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Subjects who meet all of the following criteria may be included in the study:

1. Must have a diagnosis of primary myelodysplastic syndromes (MDS) of Intermediate-1 transfusion dependent, Intermediate-2, or High-risk [defined by International Prognostic Scoring System (IPSS) score of =0.5] and recognized French-American-British (FAB) classifications

2. Male or female, 18 years of age or older with signed informed consent

3. Adequate renal function

4. Demonstrated normal liver function

5. Female subjects of childbearing age must have negative pregnancy test within 1 week of study entry and agree to use adequate contraception for the duration of the trial and for a minimum of six months after last dose of decitabine or azacitidine received.

6. Male subjects must agree to use adequate contraception for the duration of the trial and for a minimum of six months after last dose of decitabine or azacitidine received.

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from participation in the study:

1. Current use of radiotherapy for extramedullary disease for 2 weeks prior to entering study (permitted if > 2 weeks from study entry and if recovered from toxic effects of therapy)

2. Systemic fungal, bacterial, or viral infection which is not controlled (i.e., ongoing signs or symptoms of infection and without improvement despite appropriate treatment)

3. Pregnancy or current lactation

4. Significant concurrent disease, illness, or psychiatric disorder

5. Treatment with an investigational agent 30 days prior to the first dose of decitabine or azacitidine

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia

Intervention

Drug:
• decitabine
decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
• azacitidine
azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days

Locations

Country	Name	City	State
United States	Center for Cancer and Blood Disorders	Bethesda	Maryland
United States	Birmingham Hematology and Oncology Associates	Birmingham	Alabama
United States	Gabrail Cancer Center	Canton	Ohio
United States	Charleston Hematology Oncology Associates	Charleston	South Carolina
United States	University of Chicago	Chicago	Illinois
United States	Oncology and Hematology Care	Cincinnati	Ohio
United States	Carolinas Medical Center NorthEast NorthEast Oncology Associates	Concord	North Carolina
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Sletten Cancer Institute	Great Falls	Montana
United States	Gunderson Clinic Ltd.	La Crosse	Wisconsin
United States	Sarah Cannon Cancer Center	Nashville	Tennessee
United States	Pasco Pinellas Cancer Center	New Port Richey	Florida
United States	Cornell Medical Center	New York	New York
United States	University of Pittsburgh School of Medicine	Pittsburgh	Pennsylvania
United States	Utah Cancer Specialists	Salt Lake City	Utah
United States	Siouxland Haeatology - Oncology Associates	Sioux City	Iowa
United States	Gulf Coast Oncology	St. Petersburg	Florida
United States	Stanford University Cancer Center	Stanford	California
United States	Stockton Hematology Oncology	Stockton	California

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 3 Cycles of Study Drug.	Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes.; Complete Response: Bone marrow: = 5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood Hgb = 11 g/dL; Platelets = 100 X 10^9/L; Neutrophils = 1.0 X 10^9/Lb; Blasts 0%.; Marrow Complete Response: Bone marrow: = 5% myeloblasts and decrease by = 50% over pretreatment. Peripheral blood: if hematological improvement responses, they will be noted in addition to marrow CR.	13 Weeks	No
Secondary	Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 6 Cycles of Study Drug.	Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes.; Complete Response: Bone marrow: = 5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood Hgb = 11 g/dL; Platelets = 100 X 10^9/L; Neutrophils = 1.0 X 10^9/Lb; Blasts 0%.; Marrow Complete Response: Bone marrow: = 5% myeloblasts and decrease by = 50% over pretreatment. Peripheral blood: if hematological improvement responses, they will be noted in addition to marrow CR.	36 Weeks	No