The primary hypothesis is that digoxin can be safely added to decitabine and will increase the response rates in medically unfit patients with newly diagnosed AML/MDS or those with relapsed/refractory AML/MDS. Furthermore, it is hypothesized that the addition of digoxin to decitabine will result in distinct epigenetic alterations in AML/MDS patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Decitabine will be administered in combination with Digoxin
Decitabine will be administered in combination with Digoxin
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Jeans Hospital
Philadelphia, Pennsylvania, United States
Maximum Tolerated Dose of Digoxin in Combination With Standard Dose of Decitabine in Patients Newly Diagnosed AML/MDS or Those With Relapsed or Refractory AML/MDS Considered Unfit for Induction Therapy
Maximum tolerated dose of digoxin in combination with standard dose of decitabine will be determined by a standard 3+3 dose de-escalation design
Time frame: 1-2 months
Number of Grade II and IV Toxicities Due to of the Combination Therapy of Decitabine in Combination With Digoxin
The safety of the combination therapy will be determined by the number of grade III or IV non-hematologic toxicities as per NCI CTCAE v4.03 criteria.
Time frame: 1-3 years
Number of MDS Patients With Complete Remission (CR)
Complete response will be assessed by International Working Group (IWG) criteria for MDS
Time frame: 1-3 years
Number of AML Patients With Complete Remission With Incomplete Blood Count Recovery (CRi)
CRi will be assessed by IWG criteria for AML
Time frame: 1-3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.