Decitabine and Midostaurin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia (NCT01846624) | Clinical Trial Compass
TerminatedPhase 2
Decitabine and Midostaurin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Stopped: Accrual factor
United States13 participantsStarted 2013-06
Plain-language summary
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.
Who can participate
Age range60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 investi…