Phase 3
N=135
An Effectiveness and Safety Study of Decitabine in Patients With Myelodysplastic Syndrome
Myelodysplastic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01751867 ↗Enrolled (actual)
135
Serious AEs
25.8%
Results posted
Dec 2013
Primary outcome: Primary: Overall Response Rate (ORR): Number of Participants Who Achieved Either Complete Remission (CR), Partial Remission (PR), or Marrow Complete Remission (mCR) - International Working Group (IWG) 2006 Response Criteria — 10; 25 Participants — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Decitabine at 15 mg/m2 (Drug); Decitabine at 20 mg/m2 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Xian-Janssen Pharmaceutical Ltd.
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR): Number of Participants Who Achieved Either Complete Remission (CR), Partial Remission (PR), or Marrow Complete Remission (mCR) - International Working Group (IWG) 2006 Response Criteria |
10; 25 | 0.003 sig |
| SECONDARY Hematological Improvement Rate: Number of Participants Who Achieved Complete Remission (CR), Partial Remission (PR) and Hematologic Improvement (HI) - International Working Group (IWG) 2006 Response Criteria |
16; 47 | — |
| SECONDARY Cytogenetic Response Rate: Percentage of Participants Who Achieved Cytogenetic Response (Complete+Partial) by Status of Clinical Overall Response - International Working Group (IWG) 2006 Response Criteria |
66.7; 66.7; 100.0; 84.6; 100.0; 66.7 | — |
| SECONDARY Transfusion Independence: Number of Participants Who Were Transfusion Independent |
7; 37; 18; 47 | — |
| SECONDARY Mean Percentage of Duration of Hospitalization (Relative to Days on Study Treatment) |
59.6; 59.2 | — |
| SECONDARY Overall Survival Rate: Percentage of Participants Who Survived During 6 Months and 12 Months of Treatment. |
91.1; 84.7; 75.9; 65.9 | — |
| SECONDARY Mean Change From Baseline to End of Treatment in Scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ C-30) Physical Functioning Scale |
-5.5; -9.1 | — |
Summary
The purpose of this study is to evaluate the effectiveness and safety of decitabine in the treatment of myelodysplastic syndrome (name of a group of conditions that occur when the blood-forming cells in the bone marrow are damaged) in Chinese patients.
Eligibility Criteria
Inclusion Criteria
- Must have diagnosed with Myelodysplastic Syndrome (MDS) denovo (previously not present) or secondary as per the classification of French-American-British (FAB) and International Prognostic Scoring System (IPSS) greater than or eaul to 0.5 as determined by complete blood count (CBC), bone marrow assessment and bone marrow cytogenetics
- Must have an Eastern Oncology Cooperative Group (ECOG) performance status of 0-2
- Must have adequate hepatic and renal function as measured by the aspartate transaminase (AST), alanine transaminase (ALT), total bilirubin and serum creatinine, respectively
- Must have recovered from all toxic effects of prior therapy and not received any chemotherapy for a minimum of 4 weeks (6 weeks if the patient has been treated with a nitrosoureas) prior to the first dose of study drug - Woman must be postmenopausal, or surgically sterile, or abstinent, or, if sexually active, be practicing an effective method of birth control (eg, oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization)
Exclusion Criteria
- Must not have a diagnosis of acute myeloid leukemia (greater than 30% bone marrow blasts) - Must not have received radiotherapy within 14 days before the first dose of study drug - Must not have any other prior cancer, other than superficial bladder cancer, basal cell skin and cervical cancer - Must not have associated autoimmune hemolytic anemia or immune thrombocytopenia and inaspirable bone marrow - Must not have a mental illness or any other condition (eg, uncontrolled cardiac or pulmonary disease, diabetes), that could prevent full cooperation with the study requirements.
Data sourced from ClinicalTrials.gov (NCT01751867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.