Phase III study of chemotherapy in combination with ATRA with or without gemtuzumab ozogamicin in patients with acute myeloid leukemia and NPM1 gene mutatio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 588

Inclusion Criteria

Both female and male patients meeting the mentioned inclusion and exclusion criteria will be included in this clinical trial, because the risk to get AML does not depend on a patient’s gender. Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study
•Patients with confirmed diagnosis of acute myeloid leukemia according to the World Health Organization (WHO) classification
•Presence of NPM1 mutation as assessed in one of the central AMLSG reference laboratories.
•Age = 18 years. There is no upper age limit.
•No prior chemotherapy for leukemia except hydroxyurea to control hyperleukocytosis if needed for up to 5 days during the diagnostic screening phase.
•Non-pregnant and non-nursing. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within a sensitivity of at least 25 mIU/mL within 72 hours prior to registration.
•Female patients in the reproductive age and male patients must agree to avoid getting pregnant or to father a child while on therapy and within one year after the last dose of chemotherapy. Women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control - one highly effective method (e.g., IUD, hormonal, tubal ligation, or partner’s vasectomy), and one additional effective method (e.g., latex condom, diaphragm, or cervical cap). ). Women of childbearing potential” is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months.
Men must use a latex condom during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy.
•Signed written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 441
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 147

Exclusion Criteria

The presence of any of the following will exclude a patient from study enrollment:
•AML with other recurrent genetic changes (according to WHO 2008):
AML with t(8;21)(q22;q22); RUNX1-RUNX1T1
AML with inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11
AML with t(15;17)(q22;q12); PML-RARA (or other translocations involving RARA)
AML with t(9;11)(p22;q23); MLLT3-MLL (or other translocations involving MLL)
AML with t(6;9)(p23;q34); DEK-NUP214
AML with inv(3)(q21q26.2) or t(3;3)(q21;q26.2); RPN1-EVI1
•Performance status WHO >2
•Patients with ejection fraction < 50% by MUGA or ECHO scan within 14 days of day 1
•Organ insufficiency (creatinine >1.5x upper normal serum level; bilirubin, AST or ALP >2.5x upper normal serum level, not attributable to AML; heart failure NYHA III/IV; severe obstructive or restrictive ventilation disorder)
•Uncontrolled infection
•Severe neurological or psychiatric disorder interfering with ability of giving an informed consent
•Patients with a currently active” second malignancy other than non-melanoma skin cancers. Patients are not considered to have a currently active” malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year.
•Known positive for HIV,active HBV, HCV, or Hepatitis A infection
•Bleeding disorder independent of leukemia
•Patients with a currently active” second malignancy other than non-melanoma skin cancers. Patients are not considered to have a currently active” malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year.
•No consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician about study participation.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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