A multicentre, prespective, randomized controlled study of efficacy and safety of decitabine combination with low dose CAG in patients with myelodysplastic syndrome

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-TNC-11001566

Enrollment

Unknown

Registered

2011-10-20

Start date

2011-09-15

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

myelodysplastic syndrome

Interventions

PR or CR:IAG, MA, DA, AA, CAG alteranated consolidation

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Men and women, aged between 18 to 70 years; 2. Subjects have diagnosed the MDS, and IPSS >/= 0.5; 3. ECOG performance status (PS) score 0-2; 4. AST and ALT <=2.5 times the institutional ULN; Total bilirubin <=2.0 times the institutional ULN Serum creatinine<2.0 times the institutional ULN; 5. Women or men must take effective contraceptive measures, in women Serum or urine pregnancy tests must be negative in the screening and study periods; 6. Men must take effective contraceptive measures during or after treatment within 6 months; 7. Patients understand the disease and voluntarily received the study regimen and follow-up.

Exclusion criteria

Exclusion criteria: 1. Subjects have been diagnosed the AML (bone blast cell >30%); 2. Radiotherapy with 14 days; 3. History of tumors other than MDS and received any treatment in 3 years, but exclusion superficial bladder cancer, basal cell and squamous cell carcinoma, cervical intraepithelial neoplasms (CIN), prostatic intraepithelial neoplasms(PIN); 4. Activity viral or bacterial infection that would impair the ability of the subject to receive protocol therapy; 5. Concurrent autoimmune hemolytic anemia or immune thrombocytopenia; 6. Subjects have received Vidaza? or decitabine treatment, or underwent the allogeneic stem cell transplantation; 7. Subjects suffered from the AIDS?activity hepatitis B or C virus; 8. Dementia or altered mental status that would prohibit the understanding or rendering of informed consent; 9. Bone marrow aspiration was dry tap; 10. Have known to any component of decitabine allergy; 11. Lactational women.

Design outcomes

Secondary

Measure	Time frame
Hematological improvement,cytogenetic response, overall survival and blood transfusion;	—

Countries

China

Contacts

Public ContactLi Jianyong

lijianyonglm@medmail.com.cn+86 13951877733

Outcome results

None listed

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