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

  • STATUS
    Recruiting
  • participants needed
    3100
  • sponsor
    University Hospital, Angers
Updated on 25 January 2021
Investigator
Mathilde HUNAULT-BERGER, Professor
Primary Contact
CHU Estaing (0.0 mi away) Contact
+56 other location
cancer
mycophenolate mofetil
cyclosporine
methotrexate
cytarabine
filgrastim
granulocyte colony stimulating factor
induction chemotherapy
daunorubicin
idarubicin
consolidation chemotherapies
blast cells
venetoclax
colony stimulating factor
vosaroxin

Summary

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.

Details
Condition 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

Eligibility

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)
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