Trial · NCT01794702
Decitabine Followed by Clofarabine, Idarubicin, and Cytarabine in Acute Leukemia
NCT01794702, Phase 1, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2019-05-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Decitabine Followed by Clofarabine, Idarubicin, and Cytarabine in Acute Leukemia. Trials, record NCT01794702. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01794702
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Decitabine Followed by Clofarabine, Idarubicin, and Cytarabine in Acute Leukemia
- NCT number
- NCT01794702
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 65 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Leukemia
- Interventions
- Decitabine, Idarubicin, Cytarabine, Clofarabine
- First posted
- 2013-02-20
- Last updated
- 2019-05-30
- Results first posted
- 2019-05-10
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 (MTD) of Clofarabine | After second, 33 day cycle | Maximum tolerated dose (MTD) defined as the highest dose schedule in which 6 patients were treated with at most 1 experiencing a dose-limiting toxicity (DLT). Clofarabine 15 mg/m2 IV over approximately 1 hour daily (number of days selected based on Phase I portion). |
| Primary | Number of Participants With a Response | 56 days | Primary endpoint is overall response defined as the best response either complete response, complete remission without platelet recovery, or complete remission without incomplete blood count recovery within 56 days. |
| Secondary | To Determine the Disease-free Survival (DFS). | Up to 2 years after participants off study date | Time from date of treatment start until the date of first objective documentation of return of disease. |
| Secondary | Overall Survival | Up to 2 years after participants off study date | Time from date of treatment start until date of death due to any cause or last Follow-up. |
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 (MTD) of Clofarabine | After second, 33 day cycle | All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol.~Period 1: Dose level 1 - Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2: Dose level-1 - Clofarabine 15mg/m\^2 daily x 3 days (days 6-8) | mg/m^2 x 4 days (6-9) | NUMBER |
| PRIMARY | Number of Participants With a Response | 56 days | One of the 47 participants on the Phase II portion of this study who received study medication was not evaluable for response. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | To Determine the Disease-free Survival (DFS). | Up to 2 years after participants off study date | One of the 47 participants on the Phase II portion of this study who received study medication was not evaluable for response. | months | MEDIAN |
| SECONDARY | Overall Survival | Up to 2 years after participants off study date | One of the 47 participants on the Phase II portion of this study who received study medication was not evaluable for response. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of Clofarabine | Period 1 | 15 | mg/m^2 x 4 days (6-9) | ||
| Number of Participants With a Response | Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin | 20 | Participants | ||
| To Determine the Disease-free Survival (DFS). | Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin | 17.9 | Full Range 1 to 33 | months | |
| Overall Survival | Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin | 7.7 | Full Range 1 to 40 | Months |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Period 1 | 18 | |
| Overall Study | STARTED | Period 2 | 0 | |
| Overall Study | STARTED | Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin | 47 | |
| Overall Study | COMPLETED | Period 1 | 18 | |
| Overall Study | COMPLETED | Period 2 | 0 | |
| Overall Study | COMPLETED | Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin | 47 | |
| Overall Study | NOT COMPLETED | Period 1 | 0 | |
| Overall Study | NOT COMPLETED | Period 2 | 0 | |
| Overall Study | NOT COMPLETED | Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin | 0 |
Source ClinicalTrials.gov
Adverse events105
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 | Infection | Infections and infestations | Period 1 | 1 | 18 | 1 |
| other | Infection | Infections and infestations | Period 2 | 0 | ||
| other | Infection | Infections and infestations | Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin | 5 | 46 | 5 |
| other | Mucositis | Gastrointestinal disorders | Period 1 | 2 | 18 | 2 |
| other | Mucositis | Gastrointestinal disorders | Period 2 | 0 | ||
| other | Mucositis | Gastrointestinal disorders | Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin | 0 | 46 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Period 1 | 5 | 18 | 5 |
| other | Diarrhea | Gastrointestinal disorders | Period 2 | 0 | ||
| other | Diarrhea | Gastrointestinal disorders | Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin | 1 | 46 | 1 |
| other | Hyperbilirubinemia | Metabolism and nutrition disorders | Period 1 | 13 | 18 | 13 |
1 to 10 of 105Source ClinicalTrials.gov
See all 105 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Period 1 | 1 | 18 |
| Total, all-cause mortality | Period 2 | 0 | 0 |
| Total, all-cause mortality | Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin | 5 | 46 |
| Total, other adverse events | Period 1 | 17 | 18 |
| Total, other adverse events | Period 2 | 0 | 0 |
| Total, other adverse events | Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin | 27 | 46 |
| Total, serious adverse events | Period 1 | 18 | 18 |
| Total, serious adverse events | Period 2 | 0 | 0 |
| Total, serious adverse events | Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin | 33 | 46 |
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/NCT01794702
GET https://conductscience.org/api/trials/v1/NCT01794702/events?page=2