Decitabine and Midostaurin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01846624|
Recruitment Status : Terminated (Accrual factor)
First Posted : May 3, 2013
Last Update Posted : May 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia (AML) With Multilineage Dysplasia Following Myelodysplastic Syndrome, in Adults AML (Adult) With 11q23 (MLL) Abnormalities AML (Adult) With Del (5q) AML (Adult) With Inv (16) (p13; q22) AML (Adult) With t (16;16) (p13; q22) AML (Adult) With t (8; 21) (q22; q22) Secondary AML (Adult) Untreated AML (Adult)||Drug: Decitabine Drug: Midostaurin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||July 22, 2016|
|Actual Study Completion Date :||August 31, 2016|
Experimental: Decitabine, then midostaurin
INDUCTION THERAPY Subjects receive decitabine intravenously (IV) over 1 hour on days 1 to 10 and midostaurin orally (PO) twice daily (BID) on days 11 to 28. Treatment repeats every 28 days until documented bone marrow response is achieved or for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving documented bone marrow response by course 6 continue treatment with induction therapy; patients achieving response after course 6 proceed to post-remission therapy.
POST-REMISSION THERAPY Subjects receive decitabine IV over 1 hour on days 1 to 5 and midostaurin PO BID on days 6 to 28. Treatment repeats every 28 days for up to 12 courses (including induction therapy) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 1 year.
- Complete remission (CR) rate [ Time Frame: Up to 1 year ]
- Median overall survival (OS) [ Time Frame: Up to 2 years ]
- Median duration of response [ Time Frame: Up to 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01846624
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||David Iberri, MD||Stanford University Medial Center|