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

Last updated: September 27, 2024
Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Overall Status: Completed

Phase

4

Condition

Platelet Disorders

Leukemia

Acute Myeloid Leukemia

Treatment

Fludarabine

Cytarabine

Clinical Study ID

NCT02926586
CBF-AML-2016
  • Ages 18-60
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical and laboratory diagnosis of CBF-AML,including RUNX1-RUNX1T1 and CBF-MYH11fusion 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

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

Study Design

Total Participants: 68
Treatment Group(s): 2
Primary Treatment: Fludarabine
Phase: 4
Study Start date:
January 01, 2017
Estimated Completion Date:
July 31, 2024

Study Description

The recurrence rate, relapse-free survival rate, and overall survival rate of CBF-AML patients were compared between FA and HIDAC regimens. Observe the prognostic value of factors such as c-KIT gene mutation and minimal residual disease (MRD).

Connect with a study center

  • Xianmin Song

    Shanghai, Shanghai 200080
    China

    Site Not Available

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