Study of Azacitidine to Evaluate Safety and Effectiveness for Chinese Patients With Higher Risk Myelodysplastic Syndrome

NCT ID: NCT01599325

Last Updated: 2019-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-24
• Study Completion Date: 2018-03-13

Brief Summary

The purpose of the study is to determine whether azacitidine is safe and effective in the treatment of Chinese patients with higher risk Myelodysplastic Syndromes (MDS).

Conditions

Myelodysplastic Syndrome (MDS)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Azacitidine

Azacitidine 75 mg/m\^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.

Group Type: EXPERIMENTAL

Azacitidine

Intervention Type: DRUG

Subcutaneous administration of azacitidine 75 mg/m\^2/day for 7 days every 28 days optimally for at least 6 cycles until disease progression, unacceptable toxicity, or treatment discontinuation for any other reason

Interventions

Azacitidine

Subcutaneous administration of azacitidine 75 mg/m\^2/day for 7 days every 28 days optimally for at least 6 cycles until disease progression, unacceptable toxicity, or treatment discontinuation for any other reason

Intervention Type: DRUG

Other Intervention Names

Vidaza

Eligibility Criteria

Inclusion Criteria

Subjects must satisfy the following criteria to be enrolled in the study:

• Chinese males and females of Asian descent ≥ 18 years of age at the time of signing the informed consent document;
• Must have a documented diagnosis of refractory anemia with excess blasts (RAEB) or refractory anemia with excess blasts in transformation (RAEB-T) according to French-American-British (FAB) classification for Myelodysplastic Syndrome (MDS) and with an International Prognostic Scoring System (IPSS) score of intermediate-2 or high risk or a diagnosis of myelodysplastic chronic myelomonocytic leukemia (CMML) per modified FAB criteria meeting the following:

• Monocytosis in peripheral blood > 1 x 10^9/L;
• Dysplasia in one or more myeloid cell lines;
• 10% to 29% blasts in the bone marrow; and White blood cell (WBC) count < 13 x 10^9/L
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 ;
• Adequate organ function, defined as:
• Serum bilirubin ≤ 1.5 times the upper limit of normal (ULN);
• Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.0 times the ULN;
• Serum Creatinine ≤ 1.5 times the ULN;
• Females of childbearing potential (FCBP) must:
• Agree to the use of a physician-approved contraceptive method (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on azacitidine; and
• for 3 months following the last dose of azacitidine; and have a negative serum pregnancy test within 72 hours prior to starting Investigational Product (IP).
• Male subjects with a female partner of childbearing potential must agree to the use of a physician-approved contraceptive method throughout the course of the study and avoid fathering a child during the course of the study and for 3 months following the last dose of azacitidine;
• Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted;
• Able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria

The presence of any of the following will exclude a subject from enrollment:

• Previous treatment with azacitidine or decitabine;
• Diagnosis of malignant disease within the previous 12 months (excluding basal cell carcinoma of the skin without complications, "in-situ" carcinoma of the cervix or breast, or other local malignancy excised or irradiated with a high probability of cure);
• Uncorrected red cell folate deficiency or vitamin B12 deficiency;
• Diagnosis of metastatic disease;
• Malignant hepatic tumors;
• Known or suspected hypersensitivity to azacitidine or mannitol;
• Candidate to proceed to bone marrow or stem cell transplant during the study;
• Prior transplantation or cytotoxic therapy, including azacitidine and chemotherapy, administered to treat MDS;
• Treatment with erythropoietin or myeloid growth factors (granulocyte colony-stimulating factor [G-CSF] or granulocyte-macrophage colony-stimulating factor [GM-CSF]) during the 21 days prior to Day 1 of Cycle 1;
• Treatment with androgenic hormones during the 14 days prior to Day 1 of Cycle 1;
• Active viral infection with known human immunodeficiency virus (HIV) or viral hepatitis type B or C;
• Treatment with other investigational drugs, including thalidomide and arsenic trioxide, within the previous 30 days prior to Day 1 of Cycle 1, or ongoing adverse events from previous treatment with investigational drugs, regardless of the time period; and
• Pregnant or lactating females;
• Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study;
• Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study;
• Any condition that confounds the ability to interpret data from the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

C L Beach

Role: STUDY_DIRECTOR

Celgene

Locations

Peking University People's Hospital

Beijing, , China

The 301 Hospital- Chinese PLA General Hospital

Beijing, , China

The Third Hospital of Peking University

Beijing, , China

West China Hospital of Sichuan University

Chengdu, , China

Guangdong General Hospital

Guangzhou, , China

1st Hospital Zhejiang University (The First Affiliated Hospital of Zhejiang University )

Hangzhou, , China

Ruijin Hospital Shanghai Jiaotong University

Shanghai, , China

Shanghai 6th Hospital

Shanghai, , China

The 1st Hospital of Soochow University

Suzhou, , China

Blood Disease Hospital, Chinese Academy of Medical Science and Peking Union Medical College

Tianjin, , China

Wuhan Union Hospital

Wuhan, , China

Countries

China

Other Identifiers

AZA-MDS-002

Identifier Type: -

Identifier Source: org_study_id