Clinical Trials /

Fludarabine and Cytarabine Versus High-dose Cytarabine for CBF-AML

NCT02926586

Description:

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

Related Conditions:
  • Acute Myeloid Leukemia
  • Acute Myeloid Leukemia with inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11
  • Acute Myeloid Leukemia with t(8;21); (q22; q22.1); RUNX1-RUNX1T1
Recruiting Status:

Recruiting

Phase:

Phase 4

Trial Eligibility

Document

Title

  • Brief Title: Fludarabine and Cytarabine Versus High-dose Cytarabine for CBF-AML
  • Official Title: Fludarabine and Cytarabine Versus High-dose Cytarabine in Consolidation Treatment of Core-bing Factor Acute Myeloid Leukemia: A Prospective, Multicenter, Randomized Study

Clinical Trial IDs

  • ORG STUDY ID: CBF-AML-2016
  • NCT ID: NCT02926586

Conditions

  • Acute Myeloid Leukemia
  • Core-Binding Factor

Interventions

DrugSynonymsArms
FludarabineFludaraFludarabine
CytarabineCytosarhigh-dose cytarabine

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
FludarabineExperimentalThe patients in experimental arm should receive the consolidation chemotherapy regimen with fludarabine and cytarabine. The dosage of fludarabine is 30mg/m2/d for 5 days intravenously and cytarabine is 1500mg/m2/d for 5 days intravenously.
  • Fludarabine
high-dose cytarabineActive ComparatorThe patients in control arm should receive the consolidation chemotherapy regimen with high-dose cytarabine. The dosage of cytarabine is 2000mg/m2/12h for 3 days (1,3,5) intravenously.
  • Cytarabine

Eligibility Criteria

        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
      
Maximum Eligible Age:60 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percentage of participants with disease recurrence
Time Frame:one year
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Percentage of Participants in survival
Time Frame:one year
Safety Issue:
Description:

Details

Phase:Phase 4
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Trial Keywords

  • RUNX1-RUNX1T1
  • CBFβ-MYH11
  • fludarabine
  • cytarabine

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