Trial Outcomes & Findings for Dasatinib or Nilotinib Followed by Imatinib in Patients With Newly Diagnosed, Chronic Phase Chronic Myeloid Leukemia (NCT NCT02709083)
NCT ID: NCT02709083
Last Updated: 2018-11-02
Results Overview
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%).
TERMINATED
PHASE2
7 participants
At 12 months
2018-11-02
Participant Flow
Participant milestones
| Measure |
Treatment-dasatinib, Nilotinib, Imatinib
Patients receive dasatinib orally (PO) once a day (QD) or nilotinib PO twice a day (BID) at the discretion of the treating hematologist. Patients achieving either a 1 log reduction at 3 months or a 2 log reduction at 6 months in their breakpoint cluster region-abelson murine leukemia viral oncogene homolog 1 (BCR-ABL1) transcript levels may switch to imatinib mesylate PO QD.
Dasatinib: Given orally
Imatinib Mesylate: Given orally
Nilotinib: Given orally
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Treatment-dasatinib, Nilotinib, Imatinib
Patients receive dasatinib orally (PO) once a day (QD) or nilotinib PO twice a day (BID) at the discretion of the treating hematologist. Patients achieving either a 1 log reduction at 3 months or a 2 log reduction at 6 months in their breakpoint cluster region-abelson murine leukemia viral oncogene homolog 1 (BCR-ABL1) transcript levels may switch to imatinib mesylate PO QD.
Dasatinib: Given orally
Imatinib Mesylate: Given orally
Nilotinib: Given orally
|
|---|---|
|
Overall Study
Original PI left institution
|
7
|
Baseline Characteristics
Dasatinib or Nilotinib Followed by Imatinib in Patients With Newly Diagnosed, Chronic Phase Chronic Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Treatment-dasatinib, Nilotinib, Imatinib
n=7 Participants
Patients receive dasatinib orally (PO) once a day (QD) or nilotinib PO twice a day (BID) at the discretion of the treating hematologist. Patients achieving either a 1 log reduction at 3 months or a 2 log reduction at 6 months in their breakpoint cluster region-abelson murine leukemia viral oncogene homolog 1 (BCR-ABL1) transcript levels may switch to imatinib mesylate PO QD.
Dasatinib: Given orally
Imatinib Mesylate: Given orally
Nilotinib: Given orally
|
|---|---|
|
Age, Customized
Age 20-29
|
2 Participants
n=5 Participants
|
|
Age, Customized
Age 30-39
|
3 Participants
n=5 Participants
|
|
Age, Customized
Age 40-49
|
0 Participants
n=5 Participants
|
|
Age, Customized
Age 50-59
|
0 Participants
n=5 Participants
|
|
Age, Customized
Age 60-69
|
1 Participants
n=5 Participants
|
|
Age, Customized
Age 70-79
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 12 monthsPopulation: Data not collected since trial closed early; original study principal investigator Vamsi Kota, MD, left Emory University.
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%).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The time of CML diagnosis to the time of transformation to AP or BP, assessed up to 24 monthsPopulation: Data not collected since trial closed early; original study principal investigator Vamsi Kota, MD, left Emory University.
Survival will be defined as the time from CML diagnosis to the time of transformation to accelerated phase (AP) or blast phase (BP).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to up to 12 monthsPopulation: Data not collected since trial closed early; original study principal investigator Vamsi Kota, MD, left Emory University.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days after the end-of-treatmentPopulation: Data not collected since trial closed early; original study principal investigator Vamsi Kota, MD, left Emory University.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days after the end-of-treatmentPopulation: Data not collected since trial closed early; original study principal investigator Vamsi Kota, MD, left Emory University.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The time of CML diagnosis to the time of loss of MMR or loss of hematologic response, assessed up to 24 monthsPopulation: Data not collected since trial closed early; original study principal investigator Vamsi Kota, MD, left Emory University.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days after the end-of-treatmentPopulation: Data not collected since trial closed early; original study principal investigator Vamsi Kota, MD, left Emory University.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Data not collected since trial closed early; original study principal investigator Vamsi Kota, MD, left Emory University.
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.
Outcome measures
Outcome data not reported
Adverse Events
Treatment-dasatinib, Nilotinib, Imatinib
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place