Trial Outcomes & Findings for Entinostat And Imatinib Mesylate In Treating Patients With Relapsed or Refractory Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (NCT NCT01383447)
NCT ID: NCT01383447
Last Updated: 2017-08-08
Results Overview
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
TERMINATED
PHASE1/PHASE2
2 participants
Up to 30 days post-treatment
2017-08-08
Participant Flow
Participant milestones
| Measure |
Treatment (Entinostat and Imatinib Mesylate)
Patients receive entinostat PO daily on days 1, 8, 15, and 22 and imatinib mesylate PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
entinostat: Given PO
imatinib mesylate: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
western blotting: Correlative studies
immunohistochemistry staining method: Correlative studies
flow cytometry: Correlative studies
polymerase chain reaction: Correlative studies
high performance liquid chromatography: Correlative studies
mass spectrometry: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Entinostat And Imatinib Mesylate In Treating Patients With Relapsed or Refractory Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Treatment (Entinostat and Imatinib Mesylate)
n=2 Participants
Patients receive entinostat PO daily on days 1, 8, 15, and 22 and imatinib mesylate PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
entinostat: Given PO
imatinib mesylate: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
western blotting: Correlative studies
immunohistochemistry staining method: Correlative studies
flow cytometry: Correlative studies
polymerase chain reaction: Correlative studies
high performance liquid chromatography: Correlative studies
mass spectrometry: Correlative studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days post-treatmentPopulation: This study was halted prematurely by the NCI for low accrual. No results were analyzed.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days post-treatmentPopulation: This study was halted prematurely by the NCI for low accrual. No results were analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 1 yearPopulation: This study was halted prematurely by the NCI for low accrual. No results were analyzed.
The Kaplan-Meier estimator will be used to estimate PFS with a 95% confidence interval from study entry.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 4 and 11Population: This study was halted prematurely by the NCI for low accrual. No results were analyzed.
Entinostat concentrations will be compared when administered alone or in combination with imatinib by paired Student's t test (day 4 vs 11 concentrations) or Wilcoxon signed rank tests as appropriate. Association between exposure parameters and PD endpoints (e.g., apoptosis, histone acetylation, BCR-ABL expression) will be assessed using Fisher's exact tests or Wilcoxon rank sum tests as appropriate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 29Population: This study was halted prematurely by the NCI for low accrual. No results were analyzed.
Kaplan-Meier PFS curves and cumulative incidence of progression curves will be generated for patients above vs. below each threshold, and log rank will be used to compare the curves.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Entinostat and Imatinib Mesylate)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Entinostat and Imatinib Mesylate)
n=2 participants at risk
Patients receive entinostat PO daily on days 1, 8, 15, and 22 and imatinib mesylate PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
entinostat: Given PO
imatinib mesylate: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
western blotting: Correlative studies
immunohistochemistry staining method: Correlative studies
flow cytometry: Correlative studies
polymerase chain reaction: Correlative studies
high performance liquid chromatography: Correlative studies
mass spectrometry: Correlative studies
|
|---|---|
|
General disorders
Edema: lower limb
|
50.0%
1/2
|
|
Gastrointestinal disorders
nausea
|
50.0%
1/2
|
|
Psychiatric disorders
Insomnia
|
50.0%
1/2
|
|
Musculoskeletal and connective tissue disorders
Pain: bone marrow site
|
50.0%
1/2
|
|
General disorders
Fatigue
|
50.0%
1/2
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
50.0%
1/2
|
Additional Information
Dr. Patrick Brown
Johns Hopkins Sidney Kimmel Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60