Trial · NCT03113071
Safety and Activity of Digoxin With Decitabine in Adult AML and MDS
NCT03113071, Phase 1, Phase 2, Terminated, Fox Chase Cancer Center; results first posted 2021-03-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Activity of Digoxin With Decitabine in Adult AML and MDS. Trials, record NCT03113071. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03113071
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Activity of Digoxin With Decitabine in Adult AML and MDS
- NCT number
- NCT03113071
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- Fox Chase Cancer Center
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Interventions
- Decitabine, Digoxin
- First posted
- 2017-04-13
- Last updated
- 2021-03-16
- Results first posted
- 2021-03-16
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 1-2 months | Maximum tolerated dose of digoxin in combination with standard dose of decitabine will be determined by a standard 3+3 dose de-escalation design |
| Primary | Number of Grade II and IV Toxicities Due to of the Combination Therapy of Decitabine in Combination With Digoxin | 1-3 years | 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. |
| Primary | Number of MDS Patients With Complete Remission (CR) | 1-3 years | Complete response will be assessed by International Working Group (IWG) criteria for MDS |
| Primary | Number of AML Patients With Complete Remission With Incomplete Blood Count Recovery (CRi) | 1-3 years | CRi will be assessed by IWG criteria for AML |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | 1-2 months | No patients analyzed because no patients underwent protocol treatment | ||
| PRIMARY | Number of Grade II and IV Toxicities Due to of the Combination Therapy of Decitabine in Combination With Digoxin | 1-3 years | No patients analyzed because no patients underwent protocol treatment | ||
| PRIMARY | Number of MDS Patients With Complete Remission (CR) | 1-3 years | No patients analyzed because no patients underwent protocol treatment | ||
| PRIMARY | Number of AML Patients With Complete Remission With Incomplete Blood Count Recovery (CRi) | 1-3 years | No patients analyzed because no patients underwent protocol treatment |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Newly Diagnosed AML/MDS | 1 | |
| Overall Study | STARTED | Refractory or Relapsed AML/MDS | 0 | |
| Overall Study | COMPLETED | Newly Diagnosed AML/MDS | 0 | |
| Overall Study | COMPLETED | Refractory or Relapsed AML/MDS | 0 | |
| Overall Study | NOT COMPLETED | Newly Diagnosed AML/MDS | 1 | |
| Overall Study | NOT COMPLETED | Refractory or Relapsed AML/MDS | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Newly Diagnosed AML/MDS | 0 | 0 |
| Total, all-cause mortality | Refractory or Relapsed AML/MDS | 0 | 0 |
| Total, other adverse events | Newly Diagnosed AML/MDS | 0 | 0 |
| Total, other adverse events | Refractory or Relapsed AML/MDS | 0 | 0 |
| Total, serious adverse events | Newly Diagnosed AML/MDS | 0 | 0 |
| Total, serious adverse events | Refractory or Relapsed AML/MDS | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03113071
GET https://conductscience.org/api/trials/v1/NCT03113071/registered