Study to Improve OS in 18 to 60 Year-old Patients Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens and Standard Versus MMF Prophylaxis of GvHD in Allografted Patients in First CR

  • participants needed
  • sponsor
    University Hospital, Angers
Updated on 25 January 2021
mycophenolate mofetil
granulocyte colony stimulating factor
induction chemotherapy
consolidation chemotherapies
blast cells
colony stimulating factor


This open label, multicenter phase II/III study with multiple randomization phases at differents stages of AML treatment (induction, consolidation and HSCT where applicable) is designed to improve OS in younger (18 to 60 year-old) patients, with AML risk-adapted patient strategies. Within the intermediate risk AML group, optimal GvHD prophylaxis following allogeneic SCT in first CR, after either myeloablative (MAC) or reduced intensity (RIC) conditioning, will also be evaluated. With an adaptative design, this clinical trial could test up to 3 novel AML agents of interest.

Condition Acute myeloid leukemia, Acute Myelogenous Leukemia (AML), Acute myeloid leukemia, Acute Myelogenous Leukemia (AML), acute myelogenous leukemia, anll, acute myeloblastic leukemia
Treatment cyclosporine, methotrexate, Dexamethasone, Idarubicin, Daunorubicin, Mycophenolic acid (MPA), venetoclax, HD Cytarabine, vosaroxin, ID cytarabine
Clinical Study IdentifierNCT02416388
SponsorUniversity Hospital, Angers
Last Modified on25 January 2021


Yes No Not Sure

Inclusion Criteria

Patients enrolled in the BIG-1 trial at diagnosis
Patient presenting with AML in first CR or CRp/CRi treated in the BIG-1 trial and classified in the intermediate risk group, namely
either initially favorable but poor molecular responders for NPM1 MRD: NPM1 mutation, without FLT3-ITD mutation or with an FLT3-ITD ratio < 0.50 and MRD2 positive blood (decrease of less than 4 log from baseline at diagnosis))
Or initially favorable but requiring two cycles of chemotherapy (a salvage therapy) to obtain the first CR/CRp/CRi
Or other immediate intermediaries
No metastatic or progressive cancer, with the exception of basal cell skin carcinoma and cervical carcinoma in situ
Patients with general condition preserved (ECOG 3) and with no uncontrolled severe infection
Women of childbearing age must make use of effective contraception
Patients who are covered by or beneficiaries of a social security system (Social Security or Universal Medical Coverage)
Patients who have read and understood the information sheet and signed the informed consent form

Exclusion Criteria

Complete remission is not obtained (CR, CRp/CRi) after induction and/or salvage therapy
Patient presenting with AML in first CR or CRp/CRi treated in the BIG-1 trial and classified either in the favorable risk group or the unfavorable risk group
Patients with a severe organ or psychiatric pathology, presumed to be independent of AML and contraindicating the allograft
Patients who, for family, social or geographic reasons, do not wish to be regularly monitored via consultation
Uncontrolled severe infection at the time of inclusion
Serology positive for HIV 1 or 2 or HTLV 1 or 2, or active HBV or HCV viral infection
Pregnant women (beta-HCG positive) or currently breastfeeding
Adult patient who is incapacitated, under wardship, legal guardianship, or under the protection of the courts
Patients under State Medical Assistance (AME)
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