Status:
UNKNOWN
Myelodysplastic Syndrome--CDA-2 Hematological Improvement National Affirmation Study
Lead Sponsor:
Chinese Society of Hematology
Collaborating Sponsors:
Harbin Institute of Hematology & Oncology
Conditions:
Myelodysplastic Syndrome (MDS)
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief 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 patien...
Detailed Description
Patients with lower/intermediate-risk myelodysplastic syndrome (MDS) have rare therapeutic options other than supportive care. In pilot studies, CDA-2 showed promising results of hematological improve...
Eligibility Criteria
Inclusion
- 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 \</=1.5 mg/dL x Upper limit of the normal (ULN),Blood urine nitrogen (BUN)\</=1.5 mg/dL x Upper limit of the normal (ULN),Total bilirubin \</=1.5 mg/dL x Upper limit of the normal (ULN),Serum glutamic oxaloacetic transaminase/aspartate transaminase (SGOT/AST) and Serum glutamic pyruvic transaminase/alanine transaminase (SGPT/ALT)\</=2 x Upper limit of the normal (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
- 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.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT03335943
Start Date
December 1 2017
End Date
December 1 2020
Last Update
November 8 2017
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