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A Study of Decitabine Given Subcutaneously to Adults With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)

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ClinicalTrials.gov Identifier: NCT00619099
Recruitment Status : Completed
First Posted : February 20, 2008
Results First Posted : September 18, 2013
Last Update Posted : October 24, 2013
Information provided by (Responsible Party):
Eisai Inc.

February 8, 2008
February 20, 2008
July 14, 2013
September 18, 2013
October 24, 2013
May 2008
March 2012   (Final data collection date for primary outcome measure)
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.

The overall improvement rate (complete remission (CR) + partial remission (PR) + marrow (CR) + hematologic improvement (Hi)) [ Time Frame: Up to one year ]
Complete list of historical versions of study NCT00619099 on ClinicalTrials.gov Archive Site
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A Study of Decitabine Given Subcutaneously to Adults With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)
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).

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.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Myelodysplastic Syndrome
  • Drug: decitabine
    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.
    Other Name: Dacogen
  • Drug: decitabine
    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.
    Other Name: Dacogen
  • Experimental: 1
    Intervention: Drug: decitabine
  • Experimental: 2
    Intervention: Drug: decitabine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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March 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Each patient must meet the following criteria to be enrolled in this study:

  1. Male or female patients age 18 years and older.
  2. 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.
  3. Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  4. 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.
  5. 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).
  6. Women of childbearing potential and men must use contraception. Men and women must continue birth control for the duration of the study.
  7. Patients with Low or Intermediate-1 Risk MDS by the International Prognostic Scoring System (IPSS) classification.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study:

  1. Women who are pregnant or nursing.
  2. Those who have received prior therapy with decitabine.
  3. Prior therapy with azacitidine (Vidaza®).
  4. Those who received growth factor support or lenalidomide in the 30 days prior to the first dose of decitabine.
  5. Those who have received an investigational agent 30 days prior to the first dose of decitabine.
  6. 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Eisai Inc.
Eisai Inc.
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Eisai Inc.
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP