Myelodysplastic Syndrome--CDA-2 Hematological Improvement National Affirmation Study
NCT ID: NCT03335943
Last Updated: 2017-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
800 participants
INTERVENTIONAL
2017-12-01
2020-12-01
Brief Summary
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Detailed Description
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To date, the optimal regimen for CDA-2 treatment is not well established. The researchers are going to make a multi-centered clinical trial to evaluate the efficacy and safety of CDA-2 in 800 patients with International Prognostic Scoring System(IPSS) Lower/Intermediate-risk myelodysplastic syndrome (MDS).
Eligible patients will be given CDA-2 intravenously, with 200 ml each day for 14 consecutive days in every four weeks (one cycle). The treatment will be repeated at least for 3 cycles. The patients will be followed up to 24 weeks.
The primary endpoint is hematological improvement (HI) at 12 weeks according to IWG criteria. Full blood counts will be done on all patients every week. Change in bone marrow function as measured by changes in bone marrow morphology and cytogenetics will be assessed before and after 3 cycles of the treatment.
The secondary endpoint is the therapy response. Complete remission (CR), partial remission (PR) and response duration, side effects, evaluation of QOL will be evaluated at the end of the treatment in every cycle.
Adverse events of the treatment will be recorded for evaluation of the safety.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CDA-2 (Cell Differentiation Agent 2)
Patients will be given CDA-2 therapy.
CDA-2 (Cell Differentiation Agent 2)
CDA-2 will be given intravenously, with 200 ml each day for 14 consecutive days in every four weeks (one cycle). The treatment will be repeated at least for 3 cycles.
Interventions
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CDA-2 (Cell Differentiation Agent 2)
CDA-2 will be given intravenously, with 200 ml each day for 14 consecutive days in every four weeks (one cycle). The treatment will be repeated at least for 3 cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Harbin Institute of Hematology & Oncology
UNKNOWN
Chinese Society of Hematology
OTHER
Responsible Party
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Wu Depei
Professor
References
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Ma X. Epidemiology of myelodysplastic syndromes. Am J Med. 2012 Jul;125(7 Suppl):S2-5. doi: 10.1016/j.amjmed.2012.04.014.
Fenaux P, Haase D, Sanz GF, Santini V, Buske C; ESMO Guidelines Working Group. Myelodysplastic syndromes: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2014 Sep;25 Suppl 3:iii57-69. doi: 10.1093/annonc/mdu180. Epub 2014 Jul 25. No abstract available.
Related Links
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Other Identifiers
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CDA-2 MDS-2017
Identifier Type: -
Identifier Source: org_study_id