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

May 5, 2022 updated by: Xianmin Song, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200080
        • Recruiting
        • Xianmin Song

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fludarabine
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 1500mg/m2/d for 5 days intravenously.
Drug: Fludarabine
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
ACTIVE_COMPARATOR: high-dose cytarabine
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.
Drug: Cytarabine
2000mg/m2/12h, IV (in the vein) for 3 days with each cycle of 28 days. Number of cycles: 4
Other Names:
  • Cytosar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants with disease recurrence
Time Frame: one year
Comparing the percentage of participants with disease recurrence with two therapeutic regimen
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants in survival
Time Frame: one year
Comparing the percentage of Participants in survival with two therapeutic regimen
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Xianmin Song, Doctor, Department of hematology, Shanghai General Hospital, No. 100 Haining Road, Shang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

August 16, 2020

Study Completion (ANTICIPATED)

July 1, 2024

Study Registration Dates

First Submitted

October 5, 2016

First Submitted That Met QC Criteria

October 5, 2016

First Posted (ESTIMATE)

October 6, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBF-AML-2016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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