Phase
Condition
White Cell Disorders
Acute Myeloid Leukemia
Lymphoproliferative Disorders
Treatment
AT9283
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provision of signed written informed consent
Histological or cytological confirmation of one of the following: Relapsed or refractory AML or ALL; acute leukaemia in patients who are unsuitablefor or refuse standard therapy CML in chronic phase, accelerated phase or blast crisis that is resistant orrefractory to standard therapy High-risk MDS, defined as the presence of: i)Refractory anemia with excess blasts (RAEB, 5-19% bone marrow blasts) or ii)RAEB in transformation to AML (RAEBT with 20-30% bone marrow blasts) Advanced MMM defined by the presence of one or more of the following features: i)Hemoglobin < 10 gm/dL (100 g/L) ii)Platelet count < 100 x 109/L iii)White blood cell count < 4 x 109/L iv)Symptomatic splenomegaly or other disease-related symptoms inadequatelycontrolled by conventional therapies
ECOG performance status 0, 1 or 2
Male or female, age 18 years or older
Negative pregnancy test or history of surgical sterility or evidence ofpost-menopausal status (post-menopausal status is defined as any of the following:natural menopause with menses >1 year ago; radiation induced oophorectomy with lastmenses >1 year ago; chemotherapy induced menopause with 1 year interval since lastmenses
Exclusion
Exclusion Criteria:
Inadequate liver function as demonstrated by serum bilirubin ≥1.5 times the upperlimits of reference range (ULRR) or alanine aminotransferase (ALT) or aspartateaminotransferase (AST) or alkaline phosphatase (ALP) ≥2.5 times the ULRR (or ≥5times the ULRR in the presence of liver metastases)
Impaired renal function as demonstrated either by an isolated creatinine value of ≥1.5 times the ULRR OR creatinine clearance < 50 mL/min determined byCockcroft-Gault formula. Note there is no requirement to determine a formalcreatinine clearance if the patient's serum creatinine value is ≥1.5 times the ULRR.
Radiotherapy or chemotherapy within the 14 days prior to the first dose of AT9283being administered (Day 1, dose level 1). Planned use of hydroxyurea other than asis permitted as described in section 11.9.
Receiving an investigational anti-cancer treatment concurrently or within 14 daysprior to the start of AT9283 infusion (Day 1)
Unresolved CTCAE grade 2 or greater toxicity (other than stable toxicity) fromprevious anti-cancer therapy excluding alopecia
Any evidence of severe or uncontrolled systemic conditions (e.g., severe hepaticimpairment) or current unstable or uncompensated respiratory or cardiac conditionswhich makes it undesirable for the patient to participate in the study or whichcould jeopardize compliance with the protocol
Active, uncontrolled central nervous system disease
Ischemic heart disease or myocardial infarction or unstable cardiac disease within 3months of study entry
Prior infection with human immunodeficiency virus (HIV), hepatitis B or C viruses -screening for viral infections is not required for entry to this study
Major surgery within 28 days prior to the start of AT9283 infusion (Day 1) -excluding skin biopsies and procedures for insertion of central venous accessdevices
Study Design
Study Description
Connect with a study center
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesSite Not Available
The University of Texas, MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
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