Trial · NCT00621023
Cephalon Decitabine, Arsenic Trioxide and Ascorbic Acid for Myelodysplastic Syndrome
NCT00621023, Phase 2, Completed, Duke University; results first posted 2013-01-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cephalon Decitabine, Arsenic Trioxide and Ascorbic Acid for Myelodysplastic Syndrome. Trials, record NCT00621023. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00621023
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cephalon Decitabine, Arsenic Trioxide and Ascorbic Acid for Myelodysplastic Syndrome
- NCT number
- NCT00621023
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Myelodysplastic Syndrome
- Interventions
- Decitabine, Arsenic Trioxide and Ascorbic Acid
- First posted
- 2008-02-22
- Last updated
- 2013-02-04
- Results first posted
- 2013-01-28
- Limitations and caveats
- Enrollment stopped early, which lead to a small number of subjects analyzed. The subjects who were enrolled did complete the entire protocol and their data was analyzed.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With an Overall Response of Complete Response (CR) or Partial Response (PR) | after 4 cycles of therapy | Complete response and Partial response are defined using 2000 international working group (IWG) criteria. The Primary criteria for a CR is a repeat bone marrow showing \< 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia . A PR meets all the CR criteria except Blasts decreased by \>50% over pretreatment, or a less advanced myelodysplastic syndrome (MDS) French American British (FAB) classification than pretreatment. |
| Secondary | Duration of a Complete or Partial Response Based on Number of People Who Responded. | Up to 5 years or until death | Number of months a complete or partial response was maintained. |
| Secondary | Number of Patients With an Unacceptable Toxicity | During the treatment period and for 30 days after last dose of study drug | Any of the following non-hematologic toxicities that causes a patient's therapy to be suspended or discontinued: Creatinine \> 2x baseline value; serum glutamate oxaloacetate transaminase (SGOT), serum glutamate pyruvate transaminase (SGPT), Total bilirubin \> 2x the upper limit of normal; Febrile neutropenia; Uncontrolled infection; Hepatotoxicity defined as an increase in serum bilirubin, SGOT, or alkaline phosphatase to \>5 times baseline value); nephrotoxicity (defined as serum creatinine \>3.5 times the ULN); neurological impairment (defined as somnolence, seizures, or impaired mentation); severe peripheral neuropathy, or any non-hematologic grade 4 toxic event. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With an Overall Response of Complete Response (CR) or Partial Response (PR) | after 4 cycles of therapy | participants | NUMBER | |
| SECONDARY | Duration of a Complete or Partial Response Based on Number of People Who Responded. | Up to 5 years or until death | |||
| SECONDARY | Number of Patients With an Unacceptable Toxicity | During the treatment period and for 30 days after last dose of study drug | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With an Overall Response of Complete Response (CR) or Partial Response (PR) | All Participants | 0 | participants | ||
| Number of Patients With an Unacceptable Toxicity | All Participants | 4 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Participants | 6 | |
| Overall Study | COMPLETED | All Participants | 0 | |
| Overall Study | NOT COMPLETED | All Participants | 6 |
Source ClinicalTrials.gov
Adverse events62
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hemoglobin | Blood and lymphatic system disorders | All Participants | 2 | 6 | 5 |
| other | Leukocytes (total WBC) | Investigations | All Participants | 2 | 6 | 9 |
| other | Neutrophils / granulocytes (ANC / AGC) | Investigations | All Participants | 2 | 6 | 13 |
| other | Platelets | Investigations | All Participants | 2 | 6 | 7 |
| other | Prolonged QTc interval | Investigations | All Participants | 1 | 6 | 1 |
| other | Hypotension | Vascular disorders | All Participants | 1 | 6 | 1 |
| other | Fatigue (asthenia, lethargy, malaise) | General disorders | All Participants | 2 | 6 | 7 |
| other | Insomnia | Psychiatric disorders | All Participants | 1 | 6 | 1 |
| other | Rigors/chills | General disorders | All Participants | 1 | 6 | 3 |
| other | Sweating (diaphoresis) | Skin and subcutaneous tissue disorders | All Participants | 1 | 6 | 1 |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants | ||
| Total, other adverse events | All Participants | 2 | 6 |
| Total, serious adverse events | All Participants | 4 | 6 |
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/NCT00621023
GET https://conductscience.org/api/trials/v1/NCT00621023/events?page=2