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Efficacy and safety of cladribine in combination with G-CSF, low-dose cytarabine and aclarubicin in newly diagnosed elderly patients with acute myeloid leukemia: a phase 2, single center, single arm study

Efficacy and safety of cladribine in combination with G-CSF, low-dose cytarabine and aclarubicin in newly diagnosed elderly patients with acute myeloid leukemia: a phase 2, single center, single arm study

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-15007583
Enrollment
Unknown
Registered
2015-12-16
Start date
2016-01-01
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

acute myeloid leukemia

Interventions

treatment group:cladribine with CAG

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

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. 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); 2. Activity viral or bacterial infection that would impair the ability of the subject to receive protocol therapy; 3. Concurrent autoimmune hemolytic anemia or immune thrombocytopenia; 4. Subjects suffered from the AIDSactivity hepatitis B or C virus; 5. Dementia or altered mental status that would prohibit the understanding or rendering of informed consent; 6. Have known to any component of cladribine allergy.

Design outcomes

Primary

MeasureTime frame
Complete response rate after induciton chemotherapy;

Secondary

MeasureTime frame
one-year leukemia-free survival rate;one-year overall survival rate;

Contacts

Public ContactLu Yue
luyuesysucc@126.com+86 020 87342439

Outcome results

None listed

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