Myelodysplastic SyndromePhase 2NCT00619099
A Study of Decitabine Given Subcutaneously to Adults With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)
A Phase 2 study testing decitabine in people with Myelodysplastic Syndrome, run by Eisai Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to determine the effectiveness and safety of two different dose schedules of DACOGEN® (decitabine) for Injection in patients with Myelodysplastic Syndromes (MDS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome
- What is being tested?
- decitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2008to Mar 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Each patient must meet the following criteria to be enrolled in this study:
- Male or female patients age 18 years and older.
- Patients must sign an institutional review board (IRB)-approved informed consent form, and understand the investigational nature of this study and its potential hazards prior to initiation of any study-specific procedures or treatment.
- Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Adequate renal and hepatic function (creatinine < 2 times upper limit of normal, total bilirubin of < 2 times upper limit of normal, and AST and ALT ≤ 2 times upper limit of normal) unless proven to be related to disease infiltration.
- Female patients need a negative serum or urine pregnancy test within 7 days prior to study drug administration (applies only if patient is of childbearing potential. Non-childbearing is defined as ≥ 1 year postmenopausal or surgically sterilized).
- Women of childbearing potential and men must use contraception. Men and women must continue birth control for the duration of the study.
- Patients with Low or Intermediate-1 Risk MDS by the International Prognostic Scoring System (IPSS) classification.
Who cannot join
- Patients who meet any of the following criteria will be excluded from the study:
- Women who are pregnant or nursing.
- Those who have received prior therapy with decitabine.
- Prior therapy with azacitidine (Vidaza®).
- Those who received growth factor support or lenalidomide in the 30 days prior to the first dose of decitabine.
- Those who have received an investigational agent 30 days prior to the first dose of decitabine.
- Patients with active, uncontrolled, systemic infection considered opportunistic, life threatening or clinically significant; or any severe, concurrent disease, which, in the judgment of the Investigator and after discussion with the Sponsor and Primary Investigator, would make the patient inappropriate for study entry.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Gabrail Cancer Center
Canton, Ohio, 44718
M. D. Anderson
Houston, Texas, 77030
Sarah Cannon Research
Nashville, Tennessee, 37203
Landmark Medical Center
Woonsocket, Rhode Island, 02895
About this study
Official title: Randomized Open-label Phase 2 Study of Low Dose Dacogen® for Injection (Decitabine) in Patients With Low or Intermediate 1 Risk Myelodysplastic Syndromes
The purpose of this study is to determine the effectiveness and safety of two different dose schedules of DACOGEN® (decitabine) for Injection in patients with Myelodysplastic Syndromes (MDS).
Read the detailed description
This is a randomized open-label Phase 2 efficacy and safety study of two (2) subcutaneous (SQ) dosing schedules of decitabine in subjects with Low or Intermediate 1 Risk MDS. This study will be conducted in up to 6 study centers in the United States.
The primary efficacy outcome is the overall improvement rate. These two doses will be administered subcutaneously. The probability that one schedule is superior to the other will be estimated, and the level of toxicity for each schedule will also be evaluated.
- Conditions
- Myelodysplastic Syndrome
- Being tested
- decitabine
- Keywords
- Myelodysplastic Syndrome, Decitabine, Dacogen, MGI PHARMA, Inc.
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decitabineDrug
Also called Dacogen
Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
decitabineDrug
Also called Dacogen
Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: decitabine |
| 2 | Experimental | Not described Receives: Drug: decitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Overall Improvement Rate
Defined as proportion of patients having complete remission (CR), partial remission (PR), marrow complete remission (mCR), or hematologic improvement.
Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes.
Complete Remission: 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 109/L; Neutrophils ≥ 1.0 X 109/Lb; Blasts 0%.
Partial Remission: All CR criteria if abnormal before treatment except: Bone marrow blasts decreased by ≥ 50% over pretreatment but still > 5%.
Marrow Complete Remission: 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.
HI Improvement: shown in increases in hemoglobin, platelet and neutrophil response.
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startMay 2008
- Primary completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619099
- Sponsor's protocol ID
- DACO-026
- Status last verified
- Sep 2013
- First submitted
- 8 Feb 2008
- Last updated
- 24 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Garcia-Manero G, Jabbour E, Borthakur G, Faderl S, Estrov Z, Yang H, Maddipoti S, Godley LA, Gabrail N, Berdeja JG, Nadeem A, Kassalow L, Kantarjian H. Randomized open-label phase II study of decitabine in patients with low- or intermediate-risk myelodysplastic syndromes. J Clin Oncol. 2013 Jul 10;31(20):2548-53. doi: 10.1200/JCO.2012.44.6823. Epub 2013 Jun 3.
PubMed 23733767
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open-label Phase 2 Study of Low Dose Dacogen® for Injection (Decitabine) in Patients With Low or Intermediate 1 Risk Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT00619099
- Acronym / sponsor ID
- DACO-026
- Conditions
- Myelodysplastic Syndrome
- Keywords
- Myelodysplastic Syndrome, Decitabine, Dacogen, MGI PHARMA, Inc.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Mar 2012 (actual)
- First posted
- 20 Feb 2008 (estimated)
- Results
- Posted 18 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness and safety of two different dose schedules of DACOGEN® (decitabine) for Injection in patients with Myelodysplastic Syndromes (MDS).
Detailed description
This is a randomized open-label Phase 2 efficacy and safety study of two (2) subcutaneous (SQ) dosing schedules of decitabine in subjects with Low or Intermediate 1 Risk MDS. This study will be conducted in up to 6 study centers in the United States.
The primary efficacy outcome is the overall improvement rate. These two doses will be administered subcutaneously. The probability that one schedule is superior to the other will be estimated, and the level of toxicity for each schedule will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: decitabine |
| 2 | Experimental | Drug: decitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients age 18 years and older.
- Patients must sign an institutional review board (IRB)-approved informed consent form, and understand the investigational nature of this study and its potential hazards prior to initiation of any study-specific procedures or treatment.
- Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Adequate renal and hepatic function (creatinine < 2 times upper limit of normal, total bilirubin of < 2 times upper limit of normal, and AST and ALT ≤ 2 times upper limit of normal) unless proven to be related to disease infiltration.
- Female patients need a negative serum or urine pregnancy test within 7 days prior to study drug administration (applies only if patient is of childbearing potential. Non-childbearing is defined as ≥ 1 year postmenopausal or surgically sterilized).
Key exclusion criteria (7 listed)
- Women who are pregnant or nursing.
- Those who have received prior therapy with decitabine.
- Prior therapy with azacitidine (Vidaza®).
- Those who received growth factor support or lenalidomide in the 30 days prior to the first dose of decitabine.
- Those who have received an investigational agent 30 days prior to the first dose of decitabine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| decitabineAlso: DacogenSchedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days. | Drug | 1 |
| decitabineAlso: DacogenSchedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days. | Drug | 2 |
Primary outcome
The Overall Improvement Rate
Time frame: Up to one year
Defined as proportion of patients having complete remission (CR), partial remission (PR), marrow complete remission (mCR), or hematologic improvement. Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes. Complete Remission: 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 109/L; Neutrophils ≥ 1.0 X 109/Lb; Blasts 0%. Partial Remission: All CR criteria if abnormal before treatment except: Bone marrow blasts decreased by ≥ 50% over pretreatment but still > 5%. Marrow Complete Remission: 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. HI Improvement: shown in increases in hemoglobin, platelet and neutrophil response.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23733767Garcia-Manero G, Jabbour E, Borthakur G, Faderl S, Estrov Z, Yang H, Maddipoti S, Godley LA, Gabrail N, Berdeja JG, Nadeem A, Kassalow L, Kantarjian H. Randomized open-label phase II study of decitabine in patients with low- or intermediate-risk myelodysplastic syndromes. J Clin Oncol. 2013 Jul 10;31(20):2548-53. doi: 10.1200/JCO.2012.44.6823. Epub 2013 Jun 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing decitabine in people with Myelodysplastic Syndrome, run by Eisai Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Overall Improvement Rate (time frame: Up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00619099, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2013.