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The treatment of short course uroacitides (CDA -?) injection in low-risk, intermediate-1 myelodysplastic syndrome (MDS): a randomized controlled trial

The treatment of short course uroacitides (CDA -?) injection in low-risk, intermediate-1 myelodysplastic syndrome (MDS): a randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022183
Enrollment
Unknown
Registered
2019-03-29
Start date
2019-04-01
Completion date
Unknown
Last updated
2019-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndrome (MDS)

Interventions

None listed

Sponsors

Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. MDS was diagnosed in accordance with the minimum diagnostic criteria established by the Vienna conference on MDS, All of these enrolled patients presented = 1.0 of IPSS scoring, including low risk and medium risk-1 patients; 2. Aged 18 to 80 years; 3. Not used demethylation drug such as 5-azacytidine and decitabine in the past, not used differentiated drug such as All-transretinoic acid, valproic acid and arsenic trioxide in the past three months; 4. ECOG score 0-2; 5. Creatinine =1.5 fold ULNBUN=1.5 fold ULNALT=2 fold ULN,AST=2 fold ULNTbil=1.5 fold ULN; 6. Patients were treated by cell stimulating factor therapy in the past, Stop using cell stimulating factor therapy at least a month before joining the study; 7. Accurate past history and treatment history (including blood transfusion, and hemoglobin measure) in the past 8 weeks before joining the study; 8. The patient or family members understand and voluntarily signed informed consent.

Exclusion criteria

Exclusion criteria: 1. In recent 30 days, patients received other study drug therapy; 2. 5q-syndromes; 3. Patients with a history of tumor and received treatment for tumor in the past three years, in addition to the base layer of superficial bladder cancer, skin cell or squamous cell carcinoma, cervical intraepithelial cancerous (CIN) or prostate intraepithelial (PIN); 4. Patients have active viral or bacterial infections, and failure to use appropriate anti-infection treatment; 5. EPO level < 200mu/ml; 6. Patients with mental disorders or other condition and cannot cooperate research treatment and monitoring requirements; 7. Pregnancy (Women of childbearing age need to undergo pregnancy tests) and lactation; 8. HIV positive and active hepatitis patients are excluded in this study; 9. Researchers think unfavorable patients.

Design outcomes

Primary

MeasureTime frame
hematological improvement rate;

Secondary

MeasureTime frame
blood transfusion requirements;complete response;partial response;hematological improvement maintenance time;quality of life;

Countries

China

Contacts

Public ContactChang Chunkang

Shanghai Jiao Tong University Affiliated Sixth People’s Hospital

changchunkang7010@aliyun.com+86 021 24058348

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026