ClinicalTrials.Veeva

Menu

AML1-ETO Acute Myeloid Leukemia With Fludarabine and Cytarabine Chemotherapy

N

Naval Military Medical University

Status and phase

Unknown
Phase 4

Conditions

AML1-ETO Fusion Protein Expression
Acute Myeloid Leukemia

Treatments

Drug: Fludarabine
Drug: Cytarabine

Study type

Interventional

Funder types

Other

Identifiers

NCT02024308
CHXY-AML01

Details and patient eligibility

About

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 AML1-ETO acute myeloid leukemia.

Enrollment

62 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Clinical and laboratory diagnosis of AML1-ETO positive acute myeloid leukemia
  • In status of complete remission after one to two courses of induction therapy with DA(Daunorubicin 60mg/m2/d for 3 days, cytarabine 100mg/m2/d for 5-7days) regimen
  • ECOG (Eastern Cooperative Oncology Group) score: <2

Exclusion criteria

  • Serious liver/ kidney dysfunction
  • Cardiac function level: 2 above
  • Female in pregnancy or lactation
  • With serious infection diseases or other diseases

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

62 participants in 2 patient groups

Fludarabine
Experimental group
Description:
The 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 1.4g/m2/d for 5 days intravenously.
Treatment:
Drug: Cytarabine
Drug: Fludarabine
HD-Arac
Active Comparator group
Description:
The 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.
Treatment:
Drug: Cytarabine

Trial contacts and locations

1

Loading...

Central trial contact

Xianmin Song, Doctor

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems