Decitabine and Midostaurin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Trial ID or NCT#
NCT01846624
Status
NOT RECRUITING
Purpose
This phase 2 study evaluates the sequential combination of decitabine then midostaurin for the treatment of newly-diagnosed acute myeloid leukemia (AML) in older patients.
Official Title
A Phase 2 Study of Decitabine in Combination With Midostaurin (PKC412) for Elderly Patients With Newly Diagnosed FLT3-ITD/TKD Positive Acute Myeloid Leukemia
Eligibility Criteria
Ages Eligible for Study: Older than 60 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- - Newly-diagnosed acute myeloid leukemia (AML) per the World Health Organization [WHO] 2008 classification [except t (15; 17)], including: - De novo AML - Secondary AML - Secondary AML arising from previously-diagnosed myelodysplastic syndromes (MDS) treated with deoxyribonucleic acid (DNA) methyltransferase inhibitor (DNMTi) (ie, decitabine or azacitidine) - FLT3-ITD mutation confirmed in bone marrow aspirate - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) - Serum bilirubin ≤ 2.5 ULN - Serum creatinine ≤ 1.5 mg/dL and/or creatinine clearance ≥ 50 mL/min - Ejection fraction ≥ 50% by echocardiogram - Unwillingness or inability to receive conventional chemotherapy - Ability to understand and the willingness to sign a written informed consent document - Ability to adhere to the study visit schedule and other protocol requirements - Life expectancy > 2 months
Exclusion Criteria:
- - Receiving concomitant treatment with other anti-neoplastic agents (EXCEPTION: hydroxyurea). Prior treatment with DNMTi therapy (ie, decitabine or azacitidine) for MDS is allowed - Received anti-neoplastic treatment within 4 weeks prior to enrollment (EXCEPTION: hydroxyurea) - Received any surgical procedure, excluding central venous catheter placement or other minor procedures (eg, skin biopsy) within 14 days of study day 1 - Received any investigational agent within 4 weeks prior to enrollment - Previous or current history of a myeloproliferative disease - Known active central nervous system (CNS) malignancy - Any other known disease (except carcinoma in-situ), concurrent severe and/or uncontrolled medical condition which could compromise participation in the study (eg, uncontrolled diabetes; cardiovascular disease including congestive heart failure; myocardial infarction within 6 months with poorly controlled hypertension; chronic renal disease; active uncontrolled infection) - Active opportunistic infection or treatment for opportunistic infection within 4 weeks of first day of study drug dosing - Known confirmed diagnosis of human immunodeficiency virus (HIV) infection or active viral hepatitis - Known impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of midostaurin - History of allergic reactions attributed to compounds of similar chemical or biologic composition to midostaurin and/or decitabine - Impaired cardiac function including any of the following: - Screening electrocardiogram (ECG) with a corrected QT interval (QTc) > 450 msec - Bradycardia defined as heart rate (HR) < 50 beats per minute (bpm) - Right bundle branch block + left anterior hemiblock (bifascicular block) - Patients with myocardial infarction or unstable angina < 3 months prior to starting study drug - Congestive heart failure (CHF) New York (NY) Heart Association class 3 or 4 - Inability to swallow or absorb drug - Other medical or psychiatric illness or organ dysfunction or laboratory abnormality which in the opinion of the investigator would compromise the patient's safety or interfere with data interpretation - Unwillingness or inability to comply with the protocol - Pregnant - nursing (lactating) - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are using highly effective methods of contraception during dosing and for 3 months after midostaurin medication; highly effective contraception methods as follows: - Total abstinence, when this is in line with the preferred and usual lifestyle of the subject [periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception] - Female sterilization (surgical bilateral oophorectomy with or without hysterectomy; or tubal ligation at least six weeks before taking study treatment). In case of oophorectomy alone, reproductive status must be confirmed by follow-up hormone level assessment - Male sterilization, at least 6 months prior to screening (for female subjects on the study, the vasectomized male partner should be the sole partner for that subject) - Combination of any two of the following (a+b or a+c, or b+c): - Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), eg, hormone vaginal ring or transdermal hormone contraception. For oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment - Placement of an intrauterine device (IUD) or intrauterine system (IUS) - Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
CCTO
650-498-7061
View on ClinicalTrials.gov
