To Demonstrate Superiority of Decitabine Over Azacitidine in Subjects With Intermediate- or High-risk MDS.
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01011283 |
|
Recruitment Status :
Terminated
(The study was stopped due to insufficient enrollment.)
First Posted : November 11, 2009
Results First Posted : September 18, 2013
Last Update Posted : October 29, 2014
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Myelodysplastic Syndromes | Drug: decitabine Drug: azacitidine | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 26 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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) |
| Study Start Date : | November 2009 |
| Actual Primary Completion Date : | January 2011 |
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: 1 |
Drug: decitabine
decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
Other Name: Dacogen (decitabine) |
| Active Comparator: 2 |
Drug: azacitidine
azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
Other Name: Vidaza (azacitidine) |
- 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. [ Time Frame: 13 Weeks ]
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.
- 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. [ Time Frame: 36 Weeks ]
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Subjects who meet all of the following criteria may be included in the study:
- 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
- Male or female, 18 years of age or older with signed informed consent
- Adequate renal function
- Demonstrated normal liver function
- 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.
- 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:
- 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)
- Systemic fungal, bacterial, or viral infection which is not controlled (i.e., ongoing signs or symptoms of infection and without improvement despite appropriate treatment)
- Pregnancy or current lactation
- Significant concurrent disease, illness, or psychiatric disorder
- Treatment with an investigational agent 30 days prior to the first dose of decitabine or azacitidine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01011283
Show 19 study locations
| Study Director: | Karen Stein | Eisai Inc. |
| Responsible Party: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT01011283 |
| Other Study ID Numbers: |
E7373-A001-401 |
| First Posted: | November 11, 2009 Key Record Dates |
| Results First Posted: | September 18, 2013 |
| Last Update Posted: | October 29, 2014 |
| Last Verified: | October 2014 |
|
MDS Myelodysplastic Syndromes |
|
Preleukemia Myelodysplastic Syndromes Syndrome Disease Pathologic Processes Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |
Neoplasms Azacitidine Decitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors |