Decitabine+Cladribine+Cytarabine+Granulocyte Colony-stimulating Factor (D-CLAG) for Relapsed or Refractory Acute Myeloid Leukemia (AML)

  • End date
    Dec 26, 2023
  • participants needed
  • sponsor
    Zhejiang University
Updated on 5 March 2022
acute leukemia
ejection fraction
granulocyte colony stimulating factor
refractory acute myeloid leukemia (aml)
acute promyelocytic leukemia
blast cells
colony stimulating factor


A prospective, single-arm, multicenter, exploratory study to evaluate the efficacy and safety of D-CLAG regimen in the treatment of relapsed or refractory acute myeloid leukemia

Condition Acute Myeloid Leukemia
Treatment D-CLAG
Clinical Study IdentifierNCT04373395
SponsorZhejiang University
Last Modified on5 March 2022


Yes No Not Sure

Inclusion Criteria

Acute myeloid leukemia (non-acute promyelocytic leukemia) must be diagnosed before enrollment. Diagnostic criteria refer to WHO (World Health Organization) classification
Refractory or relapsed AML: refractory is defined as the failure of CR after 2 courses of standard induced remission therapy (2 courses of idarubicin+cytarabine (IA) regimen or 1 course of IA regimen + 1 course of high dose cytarabine); Relapse is defined as the blast cells >5% in bone marrow or presence of extramedullary leukemia for patient who achieved CR before
Age 18-70
Eastern cancer cooperation group (ECOG) 2
Creatinine clearance 30 mL/min (estimated glomerular filtration rate (eGFR) according to the Cockcroft-Gault formula or Modification of Diet in Renal Disease (MDRD) formula)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 3 upper limit of normal range (ULN), total bilirubin 2ULN
Echocardiography (ECHO) showed left ventricular ejection fraction (LVEF)50%
Life expectancy >8 weeks
Voluntarily sign the informed consent and understand and comply with the requirements of the study

Exclusion Criteria

White blood cell (WBC) > 50 109 / L
Patients who have received salvage treatment with D-CLAG
Current active cardiovascular disease, such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease according to the New York heart association (NYHA) functional classification, or a history of myocardial infarction within 6 months prior to screening
Other serious diseases that may limit patient participation in the trial (e.g. progressive infections, uncontrolled diabetes)
Pregnant or nursing women
Unable to understand or follow the research protocol or unable to sign the informed consent
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