Trial · NCT01498445
An Open-Label, Phase I/II Study of Two Different Schedules of Dasatinib (Sprycel) and Decitabine (Dacogen) Used in Combination for Patients With Accelerated or Blastic Phase Chronic Myelogenous Leukemia (Protocol CA180357)
NCT01498445, Phase 1, Phase 2, Terminated, M.D. Anderson Cancer Center; results first posted 2020-10-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open-Label, Phase I/II Study of Two Different Schedules of Dasatinib (Sprycel) and Decitabine (Dacogen) Used in Combination for Patients With Accelerated or Blastic Phase Chronic Myelogenous Leukemia (Protocol CA180357). Trials, record NCT01498445. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01498445
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
An Open-Label, Phase I/II Study of Two Different Schedules of Dasatinib (Sprycel) and Decitabine (Dacogen) Used in Combination for Patients With Accelerated or Blastic Phase Chronic Myelogenous Leukemia (Protocol CA180357)
- NCT number
- NCT01498445
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 32 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Leukemia
- Interventions
- Dasatinib, Decitabine, Decitabine
- First posted
- 2011-12-23
- Last updated
- 2020-10-22
- Results first posted
- 2020-10-22
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ph I Study: Maximum Tolerated Dose (MTD) Dasatinib | End of first 28-day cycle | Maximum tolerated dose (MTD) defined as highest dose at which 0 of 3 or \</= 1/6 participant experience a first cycle dose limiting toxicity (DLT). |
| Secondary | Number of Participants With Hematologic Responses During First 3 Months of Treatment | 3 months | Number of participants with hematologic response (HR) to therapy during first 3 months of combination dasatinib and decitabine therapy, where HR defined as any hematologic response observed during the first 3 months of treatment. Overall Hematologic Response (OHR) is defined as complete hematologic response (CHR), no evidence of leukemia (NEL) or minor hematologic response (MiHR) |
| Secondary | Overall Survival | Up to seven years | Overall Survival will be measured from the date treatment is started to the date of death or last follow-up. |
| Secondary | Duration of Response | up to seven years | Duration of Response will be measured from the date the given response is achieved to the date the response is first known to be lost |
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 | Ph I Study: Maximum Tolerated Dose (MTD) Dasatinib | End of first 28-day cycle | Participants who did not complete 2 cycles of therapy were ineligible for response. Maximum Tolerate Dose (MTD) was not done for the Phase II portion of the study, therefore zero participants in the Phase II arms were analyzed for this outcome. | Milligrams | NUMBER |
| SECONDARY | Number of Participants With Hematologic Responses During First 3 Months of Treatment | 3 months | 1 participant in Ph 1 Dasatinib 140 mg + Decitabine 10 mg/m\^2 arm was not evaluable for response. 2 participants in the Ph 1 Dasatinib 140 mg + Decitabine 20 mg/m\^2 arm were not evaluable for response. 1 participant in Ph II Dasatinib 140 mg + Decitabine 10mg/m\^2 and 1 participant in Ph II Dasatinib 140 mg + Decitabine 20mg/m\^2 failed screening. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | Up to seven years | 1 participant in Ph 1 Dasatinib 140 mg + Decitabine 10 mg/m\^2 arm was not evaluable for response. Two participants in the Ph 1 Dasatinib 140 mg + Decitabine 20 mg/m\^2 arm were not evaluable for response. | Months | MEDIAN |
| SECONDARY | Duration of Response | up to seven years | 1 participant in Ph 1 Dasatinib 140 mg + Decitabine 10 mg/m\^2 arm was not evaluable for response. Two participants in the Ph 1 Dasatinib 140 mg + Decitabine 20 mg/m\^2 arm were not evaluable for response. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ph I Study: Maximum Tolerated Dose (MTD) Dasatinib | Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2 | NA | Milligrams | ||
| Ph I Study: Maximum Tolerated Dose (MTD) Dasatinib | Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2 | NA | Milligrams | ||
| Ph I Study: Maximum Tolerated Dose (MTD) Dasatinib | Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2 | 140 | Milligrams | ||
| Ph I Study: Maximum Tolerated Dose (MTD) Dasatinib | Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2 | 140 | Milligrams | ||
| Number of Participants With Hematologic Responses During First 3 Months of Treatment | Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2 | 3 | Participants | ||
| Number of Participants With Hematologic Responses During First 3 Months of Treatment | Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2 | 1 | Participants | ||
| Number of Participants With Hematologic Responses During First 3 Months of Treatment | Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2 | 5 | Participants | ||
| Number of Participants With Hematologic Responses During First 3 Months of Treatment | Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2 | 4 | Participants | ||
| Number of Participants With Hematologic Responses During First 3 Months of Treatment | Phase II - Dasatinib 140 mg + Decitabine 10 mg/m2 | 3 | Participants | ||
| Number of Participants With Hematologic Responses During First 3 Months of Treatment | Phase II - Dasatinib 140 mg + Decitabine 20 mg/m2 | 3 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I Schedule A1 | 4 | |
| Overall Study | STARTED | Phase I Schedule A2 | 3 | |
| Overall Study | STARTED | Phase I Schedule B1 | 8 | |
| Overall Study | STARTED | Phase I Schedule B2 | 8 | |
| Overall Study | STARTED | Phase II B1 | 4 | |
| Overall Study | STARTED | Phase II B2 | 5 | |
| Overall Study | COMPLETED | Phase I Schedule A1 | 4 | |
| Overall Study | COMPLETED | Phase I Schedule A2 | 3 | |
| Overall Study | COMPLETED | Phase I Schedule B1 | 7 | |
| Overall Study | COMPLETED | Phase I Schedule B2 | 6 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events402
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 | Acute Kidney Injury | Renal and urinary disorders | Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2 | 0 | 4 | 0 |
| other | Acute Kidney Injury | Renal and urinary disorders | Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2 | 0 | 3 | 0 |
| other | Acute Kidney Injury | Renal and urinary disorders | Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2 | 1 | 8 | 1 |
| other | Acute Kidney Injury | Renal and urinary disorders | Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2 | 0 | 8 | 0 |
| other | Acute Kidney Injury | Renal and urinary disorders | Phase II - Dasatinib 140 mg + Decitabine 10 mg/m2 | 0 | 4 | 0 |
| other | Acute Kidney Injury | Renal and urinary disorders | Phase II - Dasatinib 140 mg + Decitabine 20 mg/m2 | 0 | 5 | 0 |
| other | Anxiety | Psychiatric disorders | Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2 | 0 | 4 | 0 |
| other | Anxiety | Psychiatric disorders | Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2 | 1 | 3 | 1 |
| other | Anxiety | Psychiatric disorders | Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2 | 3 | 8 | 3 |
| other | Anxiety | Psychiatric disorders | Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2 | 0 | 8 | 0 |
1 to 10 of 402Source ClinicalTrials.gov
See all 402 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2 | 1 | 4 |
| Total, all-cause mortality | Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2 | 1 | 3 |
| Total, all-cause mortality | Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2 | 2 | 8 |
| Total, all-cause mortality | Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2 | 0 | 8 |
| Total, all-cause mortality | Phase II - Dasatinib 140 mg + Decitabine 10 mg/m2 | 0 | 4 |
| Total, all-cause mortality | Phase II - Dasatinib 140 mg + Decitabine 20 mg/m2 | 0 | 5 |
| Total, other adverse events | Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2 | 4 | 4 |
| Total, other adverse events | Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2 | 3 | 3 |
| Total, other adverse events | Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2 | 7 | 8 |
| Total, other adverse events | Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2 | 8 | 8 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
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/NCT01498445
GET https://conductscience.org/api/trials/v1/NCT01498445/results?page=2