An Effectiveness and Safety Study of Decitabine in Patients With Myelodysplastic Syndrome

NCT01751867 | Completed Phase 3 Results

• 2 other identifiers: CR017443DACOGENMYE-3002
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of decitabine in the treatment of myelodysplastic syndrome (name of a group of conditions that occur when the blood-forming cells in the bone marrow are damaged) in Chinese patients.

Conditions

Myelodysplastic Syndrome

Keywords

Myelodysplastic Syndrome; Dacogen; Oncology; Decitabine; Bone marrow disorders

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR): Number of Participants Who Achieved Either Complete Remission (CR), Partial Remission (PR), or Marrow Complete Remission (mCR) - International Working Group (IWG) 2006 Response Criteria

  IWG 2006 response criteria - CR: bone marrow evaluation shows less than or equal to (\<=) 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin \>= 11 gram per deciliter (g/dL), neutrophils \>= 1000/mL, platelets \>= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by \>=50%, still greater than 5% in bone marrow.

  From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation

Secondary Outcomes (6)

• Hematological Improvement Rate: Number of Participants Who Achieved Complete Remission (CR), Partial Remission (PR) and Hematologic Improvement (HI) - International Working Group (IWG) 2006 Response Criteria

  From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation

• Cytogenetic Response Rate: Percentage of Participants Who Achieved Cytogenetic Response (Complete+Partial) by Status of Clinical Overall Response - International Working Group (IWG) 2006 Response Criteria

  From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation

• Transfusion Independence: Number of Participants Who Were Transfusion Independent

  Baseline; up to 2 years

• Mean Percentage of Duration of Hospitalization (Relative to Days on Study Treatment)

  Up to 2 years

• Overall Survival Rate: Percentage of Participants Who Survived During 6 Months and 12 Months of Treatment.

  From the date of dosing until death or lost to follow-up for up to 2.5 years after last patient was enrolled

Study Arms (2)

3-Day Dose schedule

EXPERIMENTAL

Decitabine will be administered at a dose of 15 mg/m2 as a continuous intravenous infusion within a 3 hour period, repeated every 8 hours for 3 consecutive days. Cycles will be repeated every 6 weeks.

Drug: Decitabine at 15 mg/m2

5-Day Dose schedule

EXPERIMENTAL

Decitabine will be administered at a dose of 20 mg/m2 as a intravenous infusion within 1 hour, once daily for 5 consecutive days. Cycles will be repeated every 4 weeks.

Drug: Decitabine at 20 mg/m2

Interventions

Decitabine at 15 mg/m2 DRUG

Decitabine will be given at a dose of 15 mg/m2 as a continuous intravenous infusion within a 3-hour intravenous infusion, repeated every 8 hours for 3 consecutive days.The total dose per day is 45 mg/m2; The total dose per course is 135 mg/m2. Cycles will be repeated every 6 weeks.

3-Day Dose schedule

Decitabine at 20 mg/m2 DRUG

Decitabine will be given at a dose of 20 mg/m2 as 1-hour IV infusion once daily on Days 1 through 5, of a 4-week treatment cycle.

5-Day Dose schedule

Eligibility Criteria

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

You may qualify if:

• Must have diagnosed with Myelodysplastic Syndrome (MDS) denovo (previously not present) or secondary as per the classification of French-American-British (FAB) and International Prognostic Scoring System (IPSS) greater than or eaul to 0.5 as determined by complete blood count (CBC), bone marrow assessment and bone marrow cytogenetics
• Must have an Eastern Oncology Cooperative Group (ECOG) performance status of 0-2
• Must have adequate hepatic and renal function as measured by the aspartate transaminase (AST), alanine transaminase (ALT), total bilirubin and serum creatinine, respectively
• Must have recovered from all toxic effects of prior therapy and not received any chemotherapy for a minimum of 4 weeks (6 weeks if the patient has been treated with a nitrosoureas) prior to the first dose of study drug - Woman must be postmenopausal, or surgically sterile, or abstinent, or, if sexually active, be practicing an effective method of birth control (eg, oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization)

You may not qualify if:

• Must not have a diagnosis of acute myeloid leukemia (greater than 30% bone marrow blasts) - Must not have received radiotherapy within 14 days before the first dose of study drug - Must not have any other prior cancer, other than superficial bladder cancer, basal cell skin and cervical cancer - Must not have associated autoimmune hemolytic anemia or immune thrombocytopenia and inaspirable bone marrow - Must not have a mental illness or any other condition (eg, uncontrolled cardiac or pulmonary disease, diabetes), that could prevent full cooperation with the study requirements.

Sponsors & Collaborators

• Xian-Janssen Pharmaceutical Ltd.: lead

Study Sites (8)

Unknown Facility

Beijing, China

Location

Unknown Facility

Chengdu, China

Location

Unknown Facility

Guangdong, China

Location

Unknown Facility

Hangzhou, China

Location

Unknown Facility

Nanjing, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Suzhou, China

Location

Unknown Facility

Tianjin, China

Location

Related Publications (1)

• Wu D, Du X, Jin J, Xiao Z, Shen Z, Shao Z, Li X, Huang X, Liu T, Yu L, Li J, Chen B, He G, Cai Z, Liang H, Li J, Ruan C. Decitabine for Treatment of Myelodysplastic Syndromes in Chinese Patients: An Open-Label, Phase-3b Study. Adv Ther. 2015 Nov;32(11):1140-59. doi: 10.1007/s12325-015-0263-8. Epub 2015 Nov 14.

  PMID: 26568466 DERIVED

MeSH Terms

Conditions

Myelodysplastic Syndromes; Neoplasms

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: SR DIR COMPD DEV TM LDR
• Organization: Janssen R&D US

1 908 704-5197

Study Officials

• Xian-Janssen Pharmaceutical Ltd Clinical Trial

  Xian-Janssen Pharmaceutical Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2012
• First Posted: December 18, 2012
• Study Start: August 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: April 1, 2013
• Last Updated: April 5, 2016
• Results First Posted: December 13, 2013

Record last verified: 2016-04

Locations

CN (8)