Acute myeloid leukemia, acute lymphoblastic leukemia or myelodysplastic syndrome. Cancer Acute myeloid leukemia
Conditions
Interventions
Capsules containing 20 mg and 100 mg of S 78454 / Oral use / Treatment duration is at the discretion of the investigator
Sponsors
Pharmacyclics LLC (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patient aged > or equal to 18 2. Ability to swallow oral capsule(s) 3. Estimated life expectancy > 8 weeks 4. ECOG performance status < or equal to 2 5. Adequate renal and hepatic functions 6. Left ventricular ejection fraction within normal limits 7. Patients with AML as defined by WHO 2008 classification, excluding acute promyelocytic leukemia 8. Patients with high or intermediary risk (IPSS int-2) myelodysplastic syndrome (MDS) as defined by WHO 2008 classification and IPSS, who have failed hypomethylating therapy (5 azacytidine) 9. Patients with histologically or cytologically confirmed B-cell ALL as defined by WHO 2008 revised classification, excluding Philadelphia chromosome-positive (Ph+) ALL (or BCR-ABL+) and B-cell ALL 3 Burkitt like, who have failed conventional or investigational therapy
Exclusion criteria
Exclusion criteria: 1. Major surgery within previous 4 weeks 2. Diagnosis of acute promyelocytic leukemia, Philadelphia chromosomepositive (Ph+) ALL (or BCR-ABL+) or B-cell ALL 3 Burkitt like 3. Patients who have not recovered from toxicity of previous antileukaemic therapy, including grade < or equal to 1 non-haematologic toxicity 4. Any previous chemotherapy for AML within at least 2 weeks (or at least 5 half-life whichever is longer), except for hydroxyureas which must be stopped within 24 hours before starting the study drug) 5. Neutrophil growth factor stimulating agent (G-CSF) within previous one week 6. Last dose of biological therapy or immunotherapy agent (therapeutic or diagnostic) less than 7 days prior to the first study drug intake 7. Any concurrent treatment with anticoagulants (curative or preventive), 8. Any radiotherapy within previous 4 weeks (except for palliative radiotherapy at localised lesions) 9. Patients with history of allogeneic stem cell transplant of less than 6 months or with active graft versus host disease requiring immune suppressive therapy 10. Patients with active disseminated intravascular coagulation (DIC) (plasma fibrinogen <1 g/L) 11. Presence of heart disorders or clinically significant heart diseases 12. Pregnant or breastfeeding women, women of child-bearing potential without effective contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. DLTs and MTDs at the end of cycle 1 - methods used: blood samples, physical examination, bone marrow samples, ECG 2. Safety profile at each visit | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pharmacokinetic and pharmacodynamic evaluations on cycle 1 and cycle 2 by blood sample 2. Response evaluation during the study by blood samples and bone marrow samples | — |
Countries
France
Outcome results
None listed