Overview

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

Status:
Completed
Trial end date:
2018-03-13
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Celgene
Celgene Corporation
Treatments:
Azacitidine
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.