Fludarabine and Cytarabine Versus High-dose Cytarabine for CBF-AML (NCT02926586) | Clinical Trial Compass
CompletedPhase 4
Fludarabine and Cytarabine Versus High-dose Cytarabine for CBF-AML
China68 participantsStarted 2017-01-01
Plain-language summary
The purpose of the study is to determine whether Fludarabine in combination with cytarabine is more effective than high-dose cytarabine in post-remission therapy for patients with core-binding factor acute myeloid leukemia
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinical and laboratory diagnosis of CBF-AML,including RUNX1-RUNX1T1 and CBF-MYH11 fusion gene rearrangement by PCR/FISH
* In status of complete remission after one to two courses of induction therapy
* Total bilirubinic acid ≤ 35μmol/L, AST/ALT\<2 times abnormal level, serum creatinine \< 1.5mg/ml
* Cardiac function: EF ≥ 50%
* Hydroxyurea can be used for patient with white blood cell count ≥ 50\*109/L
* ECOG (Eastern Cooperative Oncology Group) score: ≤ 2
Exclusion Criteria:
* Relapsed/refractory AML
* Serious liver/ kidney dysfunction
* Cardiac function level: 2 above
* Female in pregnancy or lactation
* With serious infection diseases or other diseases
* Not obey the principle of clinical study
What they're measuring
1
Percentage of participants with disease recurrence
Timeframe: one year
Trial details
NCT IDNCT02926586
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine