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Completed

NCT Number: NCT02926586

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

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

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Key information

Conditions

Acute Myeloid Leukemia Core-Binding Factor Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Xianmin Song

Shanghai, Shanghai Municipality, 200080, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fludarabine

Drug

Fludarabine 50 mg/m2, IV (in the vein) in combination with cytarabine 1500mg/m2/d for 5 days with each cycle of 28 days. Number of cycles: 4

Other names: Fludara

Cytarabine

Drug

2000mg/m2/12h, IV (in the vein) for 3 days with each cycle of 28 days. Number of cycles: 4

Other names: Cytosar

Primary outcomes

  1. Percentage of participants with disease recurrence

    Time frame: one year

    Comparing the percentage of participants with disease recurrence with two therapeutic regimen

Secondary outcomes

  1. Percentage of Participants in survival

    Time frame: one year

    Comparing the percentage of Participants in survival with two therapeutic regimen

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Fludarabine and Cytarabine Versus High-dose Cytarabine in Consolidation Treatment of Core-bing Factor Acute Myeloid Leukemia: A Prospective, Multicenter, Randomized Study

Important dates

Study start
2017
Primary completion
2020
Study completion
2024
First posted
Oct 6, 2016
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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