Trial Outcomes & Findings for Consolidation Therapy for Acute Myeloid Leukemia Guided by Leukemia Stem Cell Behavior (NCT NCT01588951)
NCT ID: NCT01588951
Last Updated: 2018-08-14
Results Overview
Percentage of participants alive and without relapsed disease at two years.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
10 participants
Primary outcome timeframe
2 years
Results posted on
2018-08-14
Participant Flow
Participant milestones
| Measure |
No Leukemia Stem Cells - Consolidation
Without LSC, standard cytarabine consolidation
Cytarabine consolidation: Cytarabine-based consolidation per institutional standards.
|
Leukemia Stem Cells - Consolidation
LSC present, randomized to cytarabine consolidation
Cytarabine consolidation: Cytarabine-based consolidation per institutional standards.
|
Leukemia Stem Cells - Transplant
LSC present, randomized to allogeneic transplant
Allogeneic transplant: Allogeneic stem cell transplant per institutional standards.
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
6
|
|
Overall Study
COMPLETED
|
2
|
2
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
No Leukemia Stem Cells - Consolidation
Without LSC, standard cytarabine consolidation
Cytarabine consolidation: Cytarabine-based consolidation per institutional standards.
|
Leukemia Stem Cells - Consolidation
LSC present, randomized to cytarabine consolidation
Cytarabine consolidation: Cytarabine-based consolidation per institutional standards.
|
Leukemia Stem Cells - Transplant
LSC present, randomized to allogeneic transplant
Allogeneic transplant: Allogeneic stem cell transplant per institutional standards.
|
|---|---|---|---|
|
Overall Study
Ineligible in retrospect
|
0
|
0
|
1
|
Baseline Characteristics
Consolidation Therapy for Acute Myeloid Leukemia Guided by Leukemia Stem Cell Behavior
Baseline characteristics by cohort
| Measure |
No Leukemia Stem Cells - Consolidation
n=2 Participants
Without LSC, standard cytarabine consolidation
Cytarabine consolidation: Cytarabine-based consolidation per institutional standards.
|
Leukemia Stem Cells - Consolidation
n=2 Participants
LSC present, randomized to cytarabine consolidation
Cytarabine consolidation: Cytarabine-based consolidation per institutional standards.
|
Leukemia Stem Cells - Transplant
n=6 Participants
LSC present, randomized to allogeneic transplant
Allogeneic transplant: Allogeneic stem cell transplant per institutional standards.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPercentage of participants alive and without relapsed disease at two years.
Outcome measures
| Measure |
No Leukemia Stem Cells - Consolidation
n=2 Participants
Without LSC, standard cytarabine consolidation
Cytarabine consolidation: Cytarabine-based consolidation per institutional standards.
|
Leukemia Stem Cells - Consolidation
n=2 Participants
LSC present, randomized to cytarabine consolidation
Cytarabine consolidation: Cytarabine-based consolidation per institutional standards.
|
Leukemia Stem Cells - Transplant
n=5 Participants
LSC present, randomized to allogeneic transplant
Allogeneic transplant: Allogeneic stem cell transplant per institutional standards.
|
|---|---|---|---|
|
Relapse Free Survival
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
No Leukemia Stem Cells - Consolidation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Leukemia Stem Cells - Consolidation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Leukemia Stem Cells - Transplant
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Margaret Showel, MD
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 410-614-0675
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place