An Efficacy and Safety Study of Decitabine in Participants With Myelodysplastic Syndrome (MDS)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00744757
• Date of registration: 29/08/2008
• Prospective Registration: No
• Primary sponsor: Johnson & Johnson Taiwan Ltd
• Public title: An Efficacy and Safety Study of Decitabine in Participants With Myelodysplastic Syndrome (MDS)
• Scientific title: A Phase II Multi-center Study of 5-AZA-2'-Deoxycytidine (Decitabine) Single Agent in Taiwanese Patients With Myelodysplastic Syndrome (MDS)
• Date of first enrolment: August 2008
• Target sample size: 37
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00744757
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Taiwan

Contacts

• Name: Johnson & Johnson Taiwan, Ltd. Clinical Trial
• Affiliation: Johnson & Johnson Taiwan Ltd

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participants with documented pathological (bone marrow, no longer than 30 days before
first dosing in study) evidence of Myelodysplastic syndromes (MDS) or of chronic
myelomonocytic leukemia (CMML) by World health organisation classification

- Participants with international prognostic scoring system (IPSS) score equal to 0.5 or
more (only for participants for whom IPSS is applicable)

- Participants with an Eastern oncology cooperative group (ECOG) performance status of
0-2

- Participants with adequate hepatic (liver) and renal (kidney) function as measured by
pre-treatment laboratory criteria within 21 days of starting treatment with decitabine

- Participants must have recovered from toxic effects of previous therapy and not
receiving any chemotherapy for a minimum of 4 weeks (6 weeks if the participants has
been treated with a nitrosoureas) before to the first dose of study drug

Exclusion Criteria:

- Participants with a diagnosis of acute myeloid leukemia (AML) (greater than 30 percent
bone marrow blasts)

- Participants with AML with multilineage dysplasia (abnormal development or cell
growth) following MDS (20-30 percent bone marrow blasts) can be enrolled. For these
latter participants an observation period of 1 month is necessary to exclude those
participants with rapid progression to full blown AML

- Participants with previous treatment with azacitadine or decitabine or hematopoietic
stem cell transplantation less than 1 year prior to study enrollment

- Participants with past history of malignancy and received any treatment for this
before malignancy within the last 3 years, except for superficial bladder cancer,
basal cell or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia
(CIN) or prostate intraepithelial neoplasia (PIN)

- Participants with known hepatitis B (surface antigen-positive) or active hepatitis C
infection



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Myelodysplastic Syndrome

Intervention(s)

Drug: Decitabine

Primary Outcome(s)

Percentage of Participants With Response [Time Frame: Day 1 of Cycle 2, 4, 6, 8; each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal)]

Secondary Outcome(s)

Overall Survival [Time Frame: Start of treatment until disease progression or death (whichever occur first) or up to 736 days]

Percentage of Participants With Transfusion Independency [Time Frame: 8 weeks before first dose and 736 days of treatment]

Number of Events Which Led to Hospitalization [Time Frame: Start of treatment until disease progression or death or up to Cycle 8, each cycle of 28 days]

Quality of Life Assessment [Time Frame: Day 1 of Cycle 1 and Cycle 8 (each cycle of 28 days)]

Duration for Hospitalization [Time Frame: Cycle 1 up to Cycle 8, each cycle of 28 days.]

Percentage of Participants With Transfusion Dependency [Time Frame: 8 weeks before first dose until disease progression or death (whichever occur first) or up to 736 days]

Time to Acute Myeloid Leukemia (AML) Progression or Death [Time Frame: Start of treatment until disease progression or death (whichever occur first) or up to 736 days]

Percentage of Participants With Hematologic Treatment Response [Time Frame: Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7 and 8, each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal)]

Percentage of Participants With Cytogenetic Response [Time Frame: Day 1 of Cycle 2, 4, 6, 8; each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal)]

Secondary ID(s)

CR014785

DACOGENMDS2001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/08/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00744757