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

  • End date
    Jul 29, 2024
  • participants needed
  • sponsor
    Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Updated on 29 May 2022
neoadjuvant therapy


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


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).

Condition Acute Myeloid Leukemia, Core-Binding Factor
Treatment cytarabine, Fludarabine
Clinical Study IdentifierNCT02926586
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Last Modified on29 May 2022


Yes No Not Sure

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 ≥ 50109/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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note