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

NCT00744757 | Completed Phase 2 Results

• 2 other identifiers: CR014785DACOGENMDS2001
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to evaluate the response rate of decitabine in previously treated and untreated Taiwanese participants with Myelodysplastic Syndrome (MDS - a disease associated with decreased production of blood cells, blood cells are produced but do not mature normally).

Conditions

Myelodysplastic Syndrome

Keywords

5-aza-2'-deoxycytidine; decitabine; dacogen; Myelodysplastic Syndrome

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Response

  Percentage of participants with response: complete response (CR) or partial response (PR) according to International Working Group (IWG) 2006 criteria was evaluated. CR in bone marrow is defined as\<=to 5% myeloblasts with normal maturation of all cell lines and persistent dysplasia was noted in peripheral blood hemoglobin \>=11 gram (g) per deciliter (dl), platelets \>=100\*10\^9 liter (l), neutrophils \>=1.0\*10\^9 l, Blasts 0%. Partial response is defined as all CR criteria if abnormal before treatment except: bone marrow blasts decreased by \>=50% over pre-treatment but still \>=5%.

  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 Outcomes (9)

• Percentage of Participants With Hematologic Treatment Response

  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

  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)

• Time to Acute Myeloid Leukemia (AML) Progression or Death

  Start of treatment until disease progression or death (whichever occur first) or up to 736 days

• Overall Survival

  Start of treatment until disease progression or death (whichever occur first) or up to 736 days

• Percentage of Participants With Transfusion Dependency

  8 weeks before first dose until disease progression or death (whichever occur first) or up to 736 days

Study Arms (1)

Decitabine

EXPERIMENTAL

Decitabine 20 milligram per square meter (mg per m\^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.

Drug: Decitabine

Interventions

Decitabine DRUG

Decitabine 20 mg per m\^2 will be administered intravenous infusion over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.

Also known as: Dacogen, 5-aza-2'-deoxycytidine

Decitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Taiwan Ltd: lead

Study Sites (6)

Unknown Facility

Changhua, Taiwan

Location

Unknown Facility

Kaohsiung City, Taiwan

Location

Unknown Facility

Taichung, Taiwan

Location

Unknown Facility

Tainan, Taiwan

Location

Unknown Facility

Taipei, Taiwan

Location

Unknown Facility

Tau-Yuan County 333, Taiwan

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Medical Director
• Organization: Medical Affairs, Janssen Taiwan

+886-2-23761255

Study Officials

• Johnson & Johnson Taiwan, Ltd. Clinical Trial

  Johnson & Johnson Taiwan Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2008
• First Posted: September 1, 2008
• Study Start: August 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: August 1, 2012
• Last Updated: September 9, 2013
• Results First Posted: August 15, 2013

Record last verified: 2013-08

Locations

TW (6)