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A perspective multi-centre random open parallel case-controlled trial of treatment of relapsed and refractory acute myeloid leukemia with Fludarabine, Cytarabine with or without G-CSF

A perspective multi-centre random open parallel case-controlled trial of treatment of relapsed and refractory acute myeloid leukemia with Fludarabine, Cytarabine with or without G-CSF

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-08000100
Enrollment
Unknown
Registered
2008-05-31
Start date
2007-12-01
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

Fludarabine+Cytarabine+G-CSF(FLAG):Fludarabine 30mg/m^2/d d1-5
Cytarabine 1.5g/m^2/d
Fludarabine+Cytarabine (FA):Fludarabine 30mg/m^2/d d1-5

Sponsors

Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 60 Years

Inclusion criteria

Inclusion criteria: The diagnosis is consistant with the FAB criteria for acute myeloid leukemia (not acute promyelocytic leukemia). The criteria for relapsed and refractory leukemia is referred to The 6th National Leukemia Conference (1991). Refractory leukemia is defined as 1. The newly diagnosed patient did not achieve complete remission after two cycles of standard regimen (HA and DA) ; 2. After complete remission, the first relapse occurred within 6 months during consolidation; or relapse after 6 month, but refractory to standard therpy; 3. multiple replased patients.

Exclusion criteria

Exclusion criteria: 1. Cardiac dysfunction, >grade II; 2.Renal or liver dysfunction, serum direct bilirubin, indirect bilirubine, ALT, AST, serum creatinine more than 1.25 times institutional upper limits of normal; 3.Female patients in labor; 4.Comboridity with other malignancies; 5.Combordity with severe infectious or metabolic disease.

Design outcomes

Primary

MeasureTime frame
Complete remission rate;Partial remission rate;Security Assessment;

Secondary

MeasureTime frame
median duration of complete remission;

Contacts

Public ContactJianmin Wang
jmwang@medmail.com.cn+86 021 25074610

Outcome results

None listed

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