An Effectiveness and Safety Study of Decitabine in Patients With Myelodysplastic Syndrome
This study is ongoing, but not recruiting participants.
Sponsor:
Xian-Janssen Pharmaceutical Ltd.
Information provided by (Responsible Party):
Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov Identifier:
NCT01751867
First received: July 25, 2012
Last updated: April 19, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myelodysplastic Syndrome |
Drug: Decitabine at 15 mg/m2 Drug: Decitabine at 20 mg/m2 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label, Multi-center, Phase IIIb Study for Decitabine in Patients With Myelodysplastic Syndrome (MDS) |
Resource links provided by NLM:
MedlinePlus related topics:
Myelodysplastic Syndromes
Drug Information available for:
Decitabine
U.S. FDA Resources
Further study details as provided by Xian-Janssen Pharmaceutical Ltd.:
Primary Outcome Measures:
- Overall response rate (ORR) [ Time Frame: From the date of randomization to the date of disease progression or death, whatever comes first, assessed up to 2 years ] [ Designated as safety issue: No ]The ORR is measured by complete response (CR)+ marrow CR (mCR)+partial response (PR) as per International working group for MDS (IWG 2006) criteria. End of treatment is defined as 30 days after last dose of study drug.
Secondary Outcome Measures:
- Number of patients with hematologic improvement [ Time Frame: From the date of randomization to the date of study discontinuation, assessed up to 2 years ] [ Designated as safety issue: No ]Hematologic improvement (HI) should be described by the number of individual, positively affected cell lines as per IWG 2006. The hematologic improvement (CR+PR+HI) rate will be calculated along with a 95% confidence interval.
- Cytogenetic response rates [ Time Frame: From the date of randomization to the date of study discontinuation, assessed up to 2 years ] [ Designated as safety issue: No ]Cytogenetic responses as per IWG 2006 will be assessed.
- Time to acute myeloid leukemia (AML) or death [ Time Frame: From the date of randomization to the date of disease progression or death, whatever comes first, assessed up to 2.2 years ] [ Designated as safety issue: No ]Time to AML transformation (greater than 30% blasts in bone marrow) or death will be calculated from the date of treatment start until disease progression to AML or until death.
- Number of transfusion requirements [ Time Frame: From the date of randomization to the date of study discontinuation, assessed up to 2 years ] [ Designated as safety issue: No ]Transfusion requirements, both for red blood cells as well as platelets, will be recorded for each patient.
- Number of days in hospital [ Time Frame: From the date of randomization to the date of study discontinuation, assessed up to 2 years ] [ Designated as safety issue: No ]Duration of hospitalization will be calculated for each patient, using the sum of number of days in hospital by subtracting the date of discharge from the date of admission.
- European Organization for Research and Treatment of Cancer Quality life questionnaire (EORTC QLQ C-30) score [ Time Frame: From the date of randomization to the date of study discontinuation, assessed up to 2 years ] [ Designated as safety issue: No ]Quality of life is measured by EORTC QLQ C-30 is a questionnaire developed to assess the quality of life of cancer patients. The score ranges from 1 (very poor) to 7 (excellent).
- Overall survival [ Time Frame: From the date of randomization to the date of disease progression or death, whatever comes first, assessed up to 2.2 years ] [ Designated as safety issue: No ]Kaplan-Meier estimation is used to measure the fraction of patients living for a certain amount of time after treatment.
- Number of patients with adverse events [ Time Frame: From the date of randomization to 30 days after last study dose, assessed up to 2 years ] [ Designated as safety issue: Yes ]Safety measures includes adverse events along with vital signs, ECG and physical examination.
| Enrollment: | 135 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | April 2013 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 3-Day Dose schedule
Decitabine will be administered at a dose of 15 mg/m2 as a continuous intravenous infusion within a 3 hour period, repeated every 8 hours for 3 consecutive days. Cycles will be repeated every 6 weeks.
|
Drug: Decitabine at 15 mg/m2
Decitabine will be given at a dose of 15 mg/m2 as a continuous intravenous infusion within a 3-hour intravenous infusion, repeated every 8 hours for 3 consecutive days.The total dose per day is 45 mg/m2; The total dose per course is 135 mg/m2. Cycles will be repeated every 6 weeks.
|
|
Experimental: 5-Day Dose schedule
Decitabine will be administered at a dose of 20 mg/m2 as a intravenous infusion within 1 hour, once daily for 5 consecutive days. Cycles will be repeated every 4 weeks.
|
Drug: Decitabine at 20 mg/m2
Decitabine will be given at a dose of 20 mg/m2 as 1-hour IV infusion once daily on Days 1 through 5, of a 4-week treatment cycle.
|
Detailed Description:
This is a prospective (look forward using periodic observations collected predominantly following patient enrollment), open-label (all people involved in the study know the identity of the assigned drug), Phase IIIb study to evaluate the efficacy and safety of decitabine in the treatment of myelodysplastic syndrome (MDS). Patients are randomized (study drug assigned by chance) in 1:1 ratio to receive treatment with decitabine either 3-day or 5-day course of therapy. When a minimum of 30 patients are reached for 3-day course of therapy, the rest of the patients will all be enrolled into 5-day course of therapy. Each patient in the study treated for a minimum of 4 cycles; however, a complete or partial response may take longer than 4 cycles. The entire study duration for each patient will be approximately two years. Safety will be evaluated for each patient by monitoring of adverse events, physical examinations, vital signs measurements, electrocardiogram, hematology and clinical chemistry testing.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Xian-Janssen Pharmaceutical Ltd. |
| ClinicalTrials.gov Identifier: | NCT01751867 History of Changes |
| Other Study ID Numbers: | CR017443, DACOGENMYE-3002 |
| Study First Received: | July 25, 2012 |
| Last Updated: | April 19, 2013 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Xian-Janssen Pharmaceutical Ltd.:
|
Myelodysplastic Syndrome Dacogen Oncology Decitabine Bone marrow disorders |
Additional relevant MeSH terms:
|
Myelodysplastic Syndromes Preleukemia Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Neoplasms Decitabine Azacitidine |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013