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Clinical Study of strictly selected patients with myelodysplastic syndrome (MDS) undergoing immunosuppressive therapy (IST)

Efficacy and Safety Study of strictly selected patients with myelodysplastic syndrome (MDS) undergoing immunosuppressive therapy (IST)

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-TNC-11001512
Enrollment
Unknown
Registered
2011-08-30
Start date
2006-08-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

low and intermediary risk MDS

Interventions

1:One part patients received antithymocyte globulin (ATG) (Fresenius Kabi Pharmaceutical Co., Ltd. Germany.) for 4 days at a dose of 4 mg/kg/day followed by cyclosporine A (Novartis Pharma Schweiz AG)

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: IPSS score 42%; CD8+/CD3+>30%; Th1/CD4+>18%; Tc1/CD8+>27%.And the patients must meet the following conditions at the same time: (1) adequate hepatic (serum bilirubin level <2*upper normal limit) and renal (serum creatinine <2*upper normal limit) function tests; (2) Performance status of =/< 2 by the ECOG scale; (3) Signed informed consent indicating that patients are aware of the clinical trail of this study; (4) Women of child bearing potential must practice contraception. Men and women must continue birth control for the duration of the trial.

Exclusion criteria

Exclusion criteria: (1) >=5% marrow myeloblasts; (2) poor karyotype according to IPSS standards; (3) diagnosis of concurrent non–hematological malignanc; (4) Nursing and pregnant females are excluded; (5) Patients with active and uncontrolled infections are excluded; (6) Patients with history of hepatitis B, C, alcoholic liver disease or evidence of hepatopathy will be excluded.

Design outcomes

Primary

MeasureTime frame
duration of response;disease progress rate;total response rates;leukemic transformation;complete response rates;Median survival;

Countries

China

Contacts

Public ContactXiao Li
lixiao3326@yahoo.com.cn+86 021 64369181-58745

Outcome results

None listed

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