Symptoms and General Pathology

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Neoplasms

Blood and Lymph Conditions

Rare Diseases

Syndrome

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Hematologic Diseases

Precancerous Conditions

Antineoplastic Agents

All Drugs and Chemicals

Decitabine

Antimetabolites

Enzyme Inhibitors

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.

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.

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.

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

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.

Eisai Inc.

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.

Schedule A: SQ 3 Consecutive Days

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.

Schedule B: SQ Once Every 7 Days

Total

Age Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Modified Intent to Treat (mITT) Population

Erhan Berrack, M.D.

Overall Improvement Rate

Complete Response

Marrow Complete Response

Partial Response

Hematologic Improvement

The Overall Improvement Rate

Overall Study

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

20 mg/m\^2, IV on days 1-5 of each 28 day cycle; until death, progression or unacceptable toxicity develops.

Eisai US Medical Services

The purpose of this study is to estimate the rate of complete remission, as well as overall survival, in older patients with Acute Myeloid Leukemia (AML).

Study of Decitabine for Treatment of Older Patients With Acute Myeloid Leukemia (AML)

A Phase II Study of Decitabine For the Front-line Treatment of Older Patients With Acute Myeloid Leukemia

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Decitabine Given Subcutaneously to Adults With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)	NCT00619099	Myelodysplastic...	decitabine decitabine	18 Years -	Eisai Inc.
Study of Decitabine for Treatment of Older Patients With Acute Myeloid Leukemia (AML)	NCT00358644	Acute Myeloid L...	Decitabine	60 Years -	Eisai Inc.
Study of Decitabine for Treatment of Older Patients With Acute Myeloid Leukemia (AML)	NCT00358644	Acute Myeloid L...	Decitabine	60 Years -	Eisai Inc.

Spots Global Cancer Trial Database for mgi pharma, inc.