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Role of pegylated liposomal doxorubicin in induction remission for myelodysplastic syndrome with excess blasts: A prospective, open-lable, multi-center study.

Role of pegylated liposomal doxorubicin in induction remission for myelodysplastic syndrome with excess blasts: A prospective, open-lable, multi-center study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019554
Enrollment
Unknown
Registered
2018-11-18
Start date
2018-11-12
Completion date
Unknown
Last updated
2019-07-01

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

Conditions

myelodysplastic syndrome with excess blasts

Interventions

Group 1:Homoharringtonine combined with cytarabine and Peg-Dox and recombinant human granulocyte colony-stimulating factor
Group 2:Decitabine?Homoharringtonine combined with cytarabine and recombinant human granulocyte colony-stimulating factor

Sponsors

Department of Hematology, Xinqiao Hospital, Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Sign an informed consent form; 2. the Male or Female aged 18 to 70 years; 3. The patients with MDS-EB with pathology,histology or flow cytometry with bone marrow; 4. The estimated survival is over three months; 5. Adequate main organ function: (1) Liver: ALT/AST 40 %; 6. Karnofsky >=60 at study entry.

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding female subject; 2. Drug abusers; 3. uncontrolled infection 4 weeks before enrolled; 4. Known positive for HIV or acute infectious hepatitis, type A, B or C; 5. other primary tumor except for AML; 6. Serious autoimmune disease or mmune deficiency disorder; 7. Central nervous involvement; 8. Serious psychiatric or psychological disorders; 9. Patients can not be enrolled which will be judged by the researchers.

Design outcomes

Primary

MeasureTime frame
Rate of complete remission;

Secondary

MeasureTime frame
Rate of minimal residual disease negativity;2-year DFS;2-year OS;Complications;Objective response rate;

Countries

China

Contacts

Public ContactZhang Xi

Department of Hematology, Xinqiao Hospital, Army Medical University, Chongqing

zhangxxi@sina.com+86 023-68755609

Outcome results

None listed

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