Trial Outcomes & Findings for Safety and Activity of Digoxin With Decitabine in Adult AML and MDS (NCT NCT03113071)
NCT ID: NCT03113071
Last Updated: 2021-03-16
Results Overview
Maximum tolerated dose of digoxin in combination with standard dose of decitabine will be determined by a standard 3+3 dose de-escalation design
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
1 participants
Primary outcome timeframe
1-2 months
Results posted on
2021-03-16
Participant Flow
Participant milestones
| Measure |
Newly Diagnosed AML/MDS
For Group#1 a total of 37 patients with newly diagnosed MDL or MDS will be enrolled, including the eligible patients originally enrolled in the phase Ib portion (safe dose group) of the study, with the goal of determining the clinical activity of our experimental regimen. In the phase II segment, all new patients who are enrolled will initially be randomized in a 1 to 1 fashion to receive decitabine alone or decitabine plus digoxin for one cycle before receiving decitabine plus digoxin for all subsequent cycles for a total of 6 cycles.
Decitabine: Decitabine will be administered in combination with Digoxin
Digoxin: Decitabine will be administered in combination with Digoxin
|
Refractory or Relapsed AML/MDS
or Group#2 the target will be to enroll a total of 60 patients with relapsed or refractory AML/MDS, including the eligible patients enrolled in the phase Ib group. This group will have randomization and treatments similar to Group#1.
Decitabine: Decitabine will be administered in combination with Digoxin
Digoxin: Decitabine will be administered in combination with Digoxin
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Newly Diagnosed AML/MDS
For Group#1 a total of 37 patients with newly diagnosed MDL or MDS will be enrolled, including the eligible patients originally enrolled in the phase Ib portion (safe dose group) of the study, with the goal of determining the clinical activity of our experimental regimen. In the phase II segment, all new patients who are enrolled will initially be randomized in a 1 to 1 fashion to receive decitabine alone or decitabine plus digoxin for one cycle before receiving decitabine plus digoxin for all subsequent cycles for a total of 6 cycles.
Decitabine: Decitabine will be administered in combination with Digoxin
Digoxin: Decitabine will be administered in combination with Digoxin
|
Refractory or Relapsed AML/MDS
or Group#2 the target will be to enroll a total of 60 patients with relapsed or refractory AML/MDS, including the eligible patients enrolled in the phase Ib group. This group will have randomization and treatments similar to Group#1.
Decitabine: Decitabine will be administered in combination with Digoxin
Digoxin: Decitabine will be administered in combination with Digoxin
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Safety and Activity of Digoxin With Decitabine in Adult AML and MDS
Baseline characteristics by cohort
| Measure |
Newly Diagnosed AML/MDS
n=1 Participants
For Group#1 a total of 37 patients with newly diagnosed MDL or MDS will be enrolled, including the eligible patients originally enrolled in the phase Ib portion (safe dose group) of the study, with the goal of determining the clinical activity of our experimental regimen. In the phase II segment, all new patients who are enrolled will initially be randomized in a 1 to 1 fashion to receive decitabine alone or decitabine plus digoxin for one cycle before receiving decitabine plus digoxin for all subsequent cycles for a total of 6 cycles.
Decitabine: Decitabine will be administered in combination with Digoxin
Digoxin: Decitabine will be administered in combination with Digoxin
|
Refractory or Relapsed AML/MDS
or Group#2 the target will be to enroll a total of 60 patients with relapsed or refractory AML/MDS, including the eligible patients enrolled in the phase Ib group. This group will have randomization and treatments similar to Group#1.
Decitabine: Decitabine will be administered in combination with Digoxin
Digoxin: Decitabine will be administered in combination with Digoxin
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-2 monthsPopulation: No patients analyzed because no patients underwent protocol treatment
Maximum tolerated dose of digoxin in combination with standard dose of decitabine will be determined by a standard 3+3 dose de-escalation design
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1-3 yearsPopulation: No patients analyzed because no patients underwent protocol treatment
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1-3 yearsPopulation: No patients analyzed because no patients underwent protocol treatment
Complete response will be assessed by International Working Group (IWG) criteria for MDS
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1-3 yearsPopulation: No patients analyzed because no patients underwent protocol treatment
CRi will be assessed by IWG criteria for AML
Outcome measures
Outcome data not reported
Adverse Events
Newly Diagnosed AML/MDS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Refractory or Relapsed AML/MDS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place