Recruiting
Phase 1
Escalation of Doses of Daratumumab in Combination With Chemotherapy (Idarubicin and Cytarabine or CPX-351) in Patients of 60 Years Old or More With Adverse Risk Acute Myeloblastic Leukemia (AML) (DARALAM)
About this study
To search for a Maximum Tolerated Dose (MTD) for the combination of daratumumab and induction chemotherapy with Idarubicin and cytarabine or CPX-351 in patients with Acute Myeloblastic Leukemia (AML) of poor prognosis
- Condition
- Adult Patients With Adverse Risk Acute Myeloblastic Leukemia
- Tested
- Darzalex
- Sponsor
- Nantes University Hospital
Who can join
- Age
- 60 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 10
- Minimum age: 60 years
- Study condition: Adult Patients With Adverse Risk Acute Myeloblastic Leukemia
- Age \>= 60 ans
- Poor prognosis AML defined according to the following criteria:1. For first-line AML:intermediate or unfavorable risk according to ELN 2022 2.for Relapsed AML:regardless of the ELN risk group
- ECOG \<= 2
- Patient eligible for intensive chemotherapy
- Who provide their written informed consent
- Liver workup: transaminases \< 3x normal, bilirubin \< 1.5 X normal
- Creatinine clearance \> 60ml/mn
- LVEF \>= 50%.
Exclusion 14
- Patients with FLT3 ITD or TKD mutation
- Patients with tuberculosis
- Patients with documented active infection with COVID 19
- Patients with hereditary fructose intolerance (HFI)
- Uncontrolled infection
- Active or past infection with Hep B, C or HIV+
- Not Affiliated with French social security system or no beneficiary from such system
- Pregnant women or patients who cannot take contraception ( contraceptive pill, abstinence, unauthorised IUD) in case of fertility. A patient who cannot continue contraception for at least 6 months after the last injection of DARATUMUMAB is not eligible for inclusion.
- Breastfeeding women
- Minors
- Adults under guardianship, curatorship or safeguard of justice
- Hypersensitivity to any of the active ingredients or excipients
- Patients with significant cardiovascular pathology including any of the following: myocardial infarction within 6 months prior to study entry, unstabilized coronary artery disease, uncontrolled hypertension, congestive heart failure.
- Patient with disease requiring systemic immunosuppressive therapy (such as high-dose steroids defined as ≥ 10mg prednisone or equivalent per day) within 4 weeks prior to the 1st scheduled dose of study treatment with the exception of dermocorticoids
Where
1 site, 1 recruiting
CHU de Nantes
Nantes, France
Contact
-
PIERRE PETERLIN
02 40 08 32 71 Pierre.PETERLIN@chu-nantes.fr
Potential match only. Final eligibility is determined by the study team.