Study of F14512 in combination with cytarabine in patients 60 years old and older with acute myeloid leukemia

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 74

Inclusion Criteria

Patients must satisfy all the following inclusion criteria before they are allowed to participate in the study:

- Cytogenetically and molecularly characterized AML according to WHO classification (excluding acute promyelocytic leukemia),

- De novo or secondary AML arising from myelodysplastic syndrome or myeloproliferative syndrome or therapy-related (if the patient is cancer-free for at least 3 years excluding non-melanoma skin cancer) who meets the following criteria:

Phase I part:
-Refractory AML after failure of one induction chemotherapy regimen or who had recurrence of disease < 3 months after CR,
-Relapsed AML: recurrence of disease superior or equal to 3 months after CR,

Phase II part:
- Refractory AML after failure of one induction chemotherapy regimen or who had recurrence of disease < 3 months after CR.
- First relapse after a first CR or CRi lasting at least 3 months but less than 24 months

- 60 years of age or older,
- WHO performance status inferior or equal to 2,
- Adequate liver function tests defined as total bilirubin inferior or equal Upper Limit of Normal (ULN), AST and ALT inferior or equal 3 x ULN,
- Adequate renal function defined as serum creatinine inferior or equal 1.5 x ULN,
- Left Ventricular Ejection Fraction (LVEF) superior or equal 45% measured by radionuclide angiography (MUGA scan) or bidimensional echography,
- No prior therapy for AML for 2 weeks before study entry and patients must have recovered from any treatment-related toxicities. Prior therapy with etoposide for prior solid tumour or AML is allowed. In case of rapidly progressive disease, the use of hydroxyurea in order to control the peripheral blood cell count is allowed; in this case, hydroxyurea should be discontinued at least 48 hours before the start of study treatment,
- Fertile men must be using an effective method of birth control throughout the study period and for up to 3 months after the last dose of study treatment if their partners are women of childbearing potential,
- The patient must have access to social insurance,
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial,
- The patient must give written (personally signed and dated) informed consent before completing any study-related procedure which means assessment or evaluation that would not form part of the normal medical care of the patient.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 74
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 74

Exclusion Criteria

If any of the following apply, the patient must not enter the study:
- Patient candidate for allograft at study entry,
- Acute promyelocytic leukaemia,
- Clinical symptoms suggesting active central nervous system leukaemia,
- Peripheral blast count superior or equal to 30.000/mm3,
- Severe complication of leukaemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, disseminated intravascular coagulation,
- Current active infection; serious concurrent, uncontrolled medical disorder,
- Thrombocytopenia refractory to platelet transfusion,
- Prior total body irradiation up to more than 12 Gy,
- Known HIV, HTLV1, Hepatitis B or C positivity,
- History of another malignancy within the past 3 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix,
- Active heart disease including myocardial infarction within the previous 6 months, symptomatic coronary artery disease, arrhythmia not controlled by medication or uncontrolled congestive heart failure [New York Heart Association NYHA class III-IV],
- Clinically relevant cardiovascular, hepatic, neurological or other systemic disease making implementation of the protocol difficult,
- Concurrent treatment with any other anti-cancer treatment,
- Participation in another trial of an investigational agent within 30 days before study entry,
- Known hypersensitivity to the study drug or to drugs with similar chemical structures,
- Concurrent treatment with inhibitors of ornithine decarboxylase or polyamine analogues,
- Chronic treatment with systemic or inhaled steroids.

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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