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Prospective study of cladribine combined with low-dose cytarabine in the treatment of higher-risk myelodysplastic syndrome patients refractory or relapsed after hypomethylation agents

Prospective study on the efficacy and safety of cladribine combined with low-dose cytarabine in the treatment of patients with higher-risk myelodysplastic syndrome refractory or relapsed after hypomethylation agents

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900026266
Enrollment
Unknown
Registered
2019-09-28
Start date
2019-12-02
Completion date
Unknown
Last updated
2019-09-30

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

Conditions

myelodysplastic syndrome

Interventions

1:Cladribine combined with cytarabine

Sponsors

Shanghai Jiaotong University Affiliated Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. MDS patients with IPSS score more than 1.0, including Intermediate-2 and high risk according to IPSS; 2. Aged 18 and 85 years; 3. Had received at least one kind of hypomethylating agents, including azacitidine or decitabine, achieved no response or relapsed after response. 4. ECOG score 0-2; 5. Creatinine <= 1.5 x ULN, BUN <= 1.5 x ULN, ALT<= 2 x ULN, AST<= 2 x ULN, Tbil<=1.5 x ULN; 6. The patient or family members understand and voluntarily signed informed consent.

Exclusion criteria

Exclusion criteria: 1. The liver and kidney functions were abnormal, which exceeded the standard of 1nclusion criteria. 2. Have a history of serious heart disease, including myocardial infarction, cardiac insufficiency grade 3-4; 3. Known HIV serological response is positive; Pregnant or lactating women; 4. There are other malignant tumors in the organs and have received any treatment for the tumors in the past three years. 5. Those who have participated in other clinical trials within one month; 6. Other researchers judged those who could not join the group.

Design outcomes

Primary

MeasureTime frame
Overall survial;

Secondary

MeasureTime frame
Overall response rate;Complete remission rate;Hematological improvement;Partial remission rate;Marrow complete remission;

Countries

China

Contacts

Public ContactChunkang Chang

Shanghai Jiaotong University Affiliated Sixth People's Hospital

changchunkang7010@aliyun.com+86 08621-24058348

Outcome results

None listed

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