Trial · NCT02709083
Dasatinib or Nilotinib Followed by Imatinib in Patients With Newly Diagnosed, Chronic Phase Chronic Myeloid Leukemia
NCT02709083, Phase 2, Terminated, Emory University; results first posted 2018-11-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dasatinib or Nilotinib Followed by Imatinib in Patients With Newly Diagnosed, Chronic Phase Chronic Myeloid Leukemia. Trials, record NCT02709083. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02709083
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasatinib or Nilotinib Followed by Imatinib in Patients With Newly Diagnosed, Chronic Phase Chronic Myeloid Leukemia
- NCT number
- NCT02709083
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- Emory University
- Conditions
- Chronic Myelogenous Leukemia, Chronic Myeloid Leukemia, Leukemia
- Interventions
- Dasatinib, Imatinib Mesylate, Nilotinib
- First posted
- 2016-03-15
- Last updated
- 2018-11-02
- Results first posted
- 2018-11-02
- Limitations and caveats
- Trial was terminated early due to original study principal investigator Vamsi Kota, MD, leaving Emory University.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Proportion of Subjects Who Achieve Major Molecular Response (MMR) | At 12 months | Response will be measured by a decrease in fusion transcript or protein resulting from the 9;22 chromosomal translocation responsible for formation of the Philadelphia Chromosome (BCR-ABL1) levels on a logarithmic scale. A 1 log reduction is a drop to below 10%, while a major molecular response (MMR) is defined as a 3 log reduction (0.1%). |
| Secondary | Accelerated Phase (AP) or Blast Phase (BP) Free Survival | The time of CML diagnosis to the time of transformation to AP or BP, assessed up to 24 months | Survival will be defined as the time from CML diagnosis to the time of transformation to accelerated phase (AP) or blast phase (BP). |
| Secondary | Change in Patient Reported Outcomes (PRO) Score Extracted From the MD Anderson Symptom Inventory-Chronic Myelogenous Leukemia (CML) | Baseline to up to 12 months | The patient reported outcomes (PRO) score extracted from the MD Anderson Symptom Inventory (MDASI)-Chronic Myelogenous Leukemia (CML) will be determined and intra and inter subject changes will be compared. |
| Secondary | Duration of Adverse Events (AEs) Using the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Criteria | Up to 30 days after the end-of-treatment | Listings of laboratory test results will also be generated, and descriptive statistics summarizing the changes in laboratory tests over time will be presented. Exposure to drug over time will also be summarized. The AE incidence rates, as well as the frequency of occurrence of overall toxicity, categorized by toxicity grades (severity) will be described as obtained from subject forms and subject communications. |
| Secondary | Frequency of Adverse Events (AEs) Using the Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE v4.03) Criteria | Up to 30 days after the end-of-treatment | Listings of laboratory test results will also be generated, and descriptive statistics summarizing the changes in laboratory tests over time will be presented. Exposure to drug over time will also be summarized. The AE incidence rates, as well as the frequency of occurrence of overall toxicity, categorized by toxicity grades (severity) will be described as obtained from subject forms and subject communications. |
| Secondary | Progression Free Survival (PFS) | The time of CML diagnosis to the time of loss of MMR or loss of hematologic response, assessed up to 24 months | Progression free survival (PFS) will be defined as the time from CML diagnosis to the time of loss of major molecular response (MMR) or loss of hematologic response. |
| Secondary | Severity of Adverse Events (AEs) Using the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Criteria | Up to 30 days after the end-of-treatment | Listings of laboratory test results will also be generated, and descriptive statistics summarizing the changes in laboratory tests over time will be presented. Exposure to drug over time will also be summarized. The AE incidence rates, as well as the frequency of occurrence of overall toxicity, categorized by toxicity grades (severity) will be described as obtained from subject forms and subject communications. |
| Secondary | The Number of Subjects With Breakpoint Cluster Region-abelson Murine Leukemia Viral Oncogene Homolog 1 (BCR-ABL1) Transcript Levels ≤ Deep Molecular Responses (MR⁴) | Up to 24 months | Descriptive statistics will summarize the changes in breakpoint cluster region-abelson murine leukemia viral oncogene homolog 1 (BCR-ABL1) testing over time will be presented. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Proportion of Subjects Who Achieve Major Molecular Response (MMR) | At 12 months | Data not collected since trial closed early; original study principal investigator Vamsi Kota, MD, left Emory University. | ||
| SECONDARY | Accelerated Phase (AP) or Blast Phase (BP) Free Survival | The time of CML diagnosis to the time of transformation to AP or BP, assessed up to 24 months | Data not collected since trial closed early; original study principal investigator Vamsi Kota, MD, left Emory University. | ||
| SECONDARY | Change in Patient Reported Outcomes (PRO) Score Extracted From the MD Anderson Symptom Inventory-Chronic Myelogenous Leukemia (CML) | Baseline to up to 12 months | Data not collected since trial closed early; original study principal investigator Vamsi Kota, MD, left Emory University. | ||
| SECONDARY | Duration of Adverse Events (AEs) Using the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Criteria | Up to 30 days after the end-of-treatment | Data not collected since trial closed early; original study principal investigator Vamsi Kota, MD, left Emory University. | ||
| SECONDARY | Frequency of Adverse Events (AEs) Using the Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE v4.03) Criteria | Up to 30 days after the end-of-treatment | Data not collected since trial closed early; original study principal investigator Vamsi Kota, MD, left Emory University. | ||
| SECONDARY | Progression Free Survival (PFS) | The time of CML diagnosis to the time of loss of MMR or loss of hematologic response, assessed up to 24 months | Data not collected since trial closed early; original study principal investigator Vamsi Kota, MD, left Emory University. | ||
| SECONDARY | Severity of Adverse Events (AEs) Using the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Criteria | Up to 30 days after the end-of-treatment | Data not collected since trial closed early; original study principal investigator Vamsi Kota, MD, left Emory University. | ||
| SECONDARY | The Number of Subjects With Breakpoint Cluster Region-abelson Murine Leukemia Viral Oncogene Homolog 1 (BCR-ABL1) Transcript Levels ≤ Deep Molecular Responses (MR⁴) | Up to 24 months | Data not collected since trial closed early; original study principal investigator Vamsi Kota, MD, left Emory University. |
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 flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment-dasatinib, Nilotinib, Imatinib | 7 | |
| Overall Study | COMPLETED | Treatment-dasatinib, Nilotinib, Imatinib | 0 | |
| Overall Study | NOT COMPLETED | Treatment-dasatinib, Nilotinib, Imatinib | 7 |
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 totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment-dasatinib, Nilotinib, Imatinib | 0 | 7 |
| Total, other adverse events | Treatment-dasatinib, Nilotinib, Imatinib | 0 | 7 |
| Total, serious adverse events | Treatment-dasatinib, Nilotinib, Imatinib | 0 | 7 |
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/NCT02709083
GET https://conductscience.org/api/trials/v1/NCT02709083/registered