Overview

Myelodysplastic Syndrome--CDA-2 Hematological Improvement National Affirmation Study

Status:
Unknown status
Trial end date:
2020-12-01
Target enrollment:
0
Participant gender:
All
Summary
This Study aims to evaluate the efficacy and safety of CDA-2 in the treatment of International Prognostic Scoring System (IPSS) Lower/Intermediate-risk myelodysplastic syndrome (MDS) in Chinese patients.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chinese Society of Hematology
Collaborator:
Harbin Institute of Hematology & Oncology
Criteria
Inclusion Criteria:

- Documented diagnosis of MDS according to World Health Organization (WHO)/French
American British (FAB) classification that meets IPSS-R classification of low, or
intermediate-1 risk disease.

- Subject is 18 to 85years of age the time of signing the informed consent form (ICF).

- Able to adhere to the study visit schedule and other protocol requirements

- Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2.

- Laboratory test results within these ranges: Serum creatinine limit of the normal (ULN),Blood urine nitrogen (BUN) normal (ULN),Total bilirubin glutamic oxaloacetic transaminase/aspartate transaminase (SGOT/AST) and Serum glutamic
pyruvic transaminase/alanine transaminase (SGPT/ALT) (ULN).

- No prior intensive combination chemotherapy or dose Azacitidine,Decitabine,and
Lenalidomide,etc.

- Capable of understanding the investigational nature, potential risks and benefits of
the study, and able to provide valid informed consent.

Exclusion Criteria:

- IPSS risk group intermediate-2 or high risk

- breast feeding and pregnant women

- MDS associated with del 5q cytogenetic abnormality

- Patients with history of hepatitis B, C, HIV(+), alcoholic liver disease or evidence
of hepatopathy will be excluded.

- Any significant concurrent disease, illness, or psychiatric disorder that would
compromise patient safety or compliance, interfere with consent, study participation,
follow up, or interpretation of study results.