Trial Outcomes & Findings for Targeted Therapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia (NCT NCT01620216)
NCT ID: NCT01620216
Last Updated: 2021-11-04
Results Overview
Will be defined as defined as a decrease of at least 25% in bone marrow blast counts or peripheral blood blast. The proportion of patients achieving the endpoint along with its 95% exact binomial confidence interval will be presented.
TERMINATED
PHASE2
12 participants
Up to 28 days
2021-11-04
Participant Flow
Participant milestones
| Measure |
Group I (Dasatinib)
Patients receive dasatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Dasatinib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
Group II (Sutinib Malate)
Patients receive sutinib malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Sunitinib: Given PO
Sunitinib Malate: Given PO
|
Group III (Sorafenib Tosylate)
Patients receive sorafenib tosylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Sorafenib: Given PO
Sorafenib Tosylate: Given PO
|
Group IV (Ponatinib Hydrochloride)
Patients receive ponatinib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Ponatinib: Given PO
Ponatinib Hydrochloride: Given PO
|
Group V (Pacritinib)
Patients receive pacritinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pacritinib: Given PO
Pharmacological Study: Correlative studies
|
Group VI (Ruxolitinib)
Patients receive ruxolitinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Ruxolitinib: Given PO
|
Group VII (Idelalisib)
Patients receive idelalisib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Idelalisib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
6
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
4
|
2
|
6
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Targeted Therapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia
Baseline characteristics by cohort
| Measure |
Group I (Dasatinib)
n=4 Participants
Patients receive dasatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Dasatinib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
Group II (Sutinib Malate)
n=2 Participants
Patients receive sutinib malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Sunitinib: Given PO
Sunitinib Malate: Given PO
|
Group III (Sorafenib Tosylate)
n=6 Participants
Patients receive sorafenib tosylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Sorafenib: Given PO
Sorafenib Tosylate: Given PO
|
Group IV (Ponatinib Hydrochloride)
Patients receive ponatinib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Ponatinib: Given PO
Ponatinib Hydrochloride: Given PO
|
Group V (Pacritinib)
Patients receive pacritinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pacritinib: Given PO
Pharmacological Study: Correlative studies
|
Group VI (Ruxolitinib)
Patients receive ruxolitinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Ruxolitinib: Given PO
|
Group VII (Idelalisib)
Patients receive idelalisib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Idelalisib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
70.5 Years
n=5 Participants
|
50 Years
n=7 Participants
|
57.5 Years
n=5 Participants
|
—
|
—
|
—
|
—
|
63 Years
n=24 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
7 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
5 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
9 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
3 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: Zero patients enrolled in Ponatinib, Pacrtitinib, Ruxolitinib, and Idealisib arms.
Will be defined as defined as a decrease of at least 25% in bone marrow blast counts or peripheral blood blast. The proportion of patients achieving the endpoint along with its 95% exact binomial confidence interval will be presented.
Outcome measures
| Measure |
Group I (Dasatinib)
n=4 Participants
Patients receive dasatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Dasatinib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
Group II (Sutinib Malate)
n=2 Participants
Patients receive sutinib malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Sunitinib: Given PO
Sunitinib Malate: Given PO
|
Group III (Sorafenib Tosylate)
n=6 Participants
Patients receive sorafenib tosylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Sorafenib: Given PO
Sorafenib Tosylate: Given PO
|
Group IV (Ponatinib Hydrochloride)
Patients receive ponatinib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Ponatinib: Given PO
Ponatinib Hydrochloride: Given PO
|
Group V (Pacritinib)
Patients receive pacritinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pacritinib: Given PO
Pharmacological Study: Correlative studies
|
Group VI (Ruxolitinib)
Patients receive ruxolitinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Ruxolitinib: Given PO
|
Group VII (Idelalisib)
Patients receive idelalisib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Idelalisib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|---|---|---|---|---|---|
|
Clinical Activity
|
1 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
Per Response Evaluation Criteria in AML or ALL: Complete Response (CR), at least \<5% bone marrow blasts; Partial Response (PR), reduction of \>=50% bone marrow blasts; Overall Response (OR)= CR + PR. The proportion of patients achieving the endpoint along with its 95% exact binomial confidence interval will be presented.
Outcome measures
| Measure |
Group I (Dasatinib)
n=4 Participants
Patients receive dasatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Dasatinib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
Group II (Sutinib Malate)
n=2 Participants
Patients receive sutinib malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Sunitinib: Given PO
Sunitinib Malate: Given PO
|
Group III (Sorafenib Tosylate)
n=6 Participants
Patients receive sorafenib tosylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Sorafenib: Given PO
Sorafenib Tosylate: Given PO
|
Group IV (Ponatinib Hydrochloride)
Patients receive ponatinib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Ponatinib: Given PO
Ponatinib Hydrochloride: Given PO
|
Group V (Pacritinib)
Patients receive pacritinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pacritinib: Given PO
Pharmacological Study: Correlative studies
|
Group VI (Ruxolitinib)
Patients receive ruxolitinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Ruxolitinib: Given PO
|
Group VII (Idelalisib)
Patients receive idelalisib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Idelalisib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|---|---|---|---|---|---|
|
Overall Objective Response Rates (Complete and Partial)
Partial response
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Overall Objective Response Rates (Complete and Partial)
Progressive disease
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Overall Objective Response Rates (Complete and Partial)
Stable disease
|
2 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Overall Objective Response Rates (Complete and Partial)
Not assessable
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the start of study drug treatment to death, regardless of cause of death, or date of disease progression defined as a >= 50% increase in leukemic bone marrow blasts, whichever occurs first, assessed up to 3 yearsPopulation: Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
Kaplan-Meier method will be used to estimate the survival curve.
Outcome measures
| Measure |
Group I (Dasatinib)
n=4 Participants
Patients receive dasatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Dasatinib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
Group II (Sutinib Malate)
n=2 Participants
Patients receive sutinib malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Sunitinib: Given PO
Sunitinib Malate: Given PO
|
Group III (Sorafenib Tosylate)
n=6 Participants
Patients receive sorafenib tosylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Sorafenib: Given PO
Sorafenib Tosylate: Given PO
|
Group IV (Ponatinib Hydrochloride)
Patients receive ponatinib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Ponatinib: Given PO
Ponatinib Hydrochloride: Given PO
|
Group V (Pacritinib)
Patients receive pacritinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pacritinib: Given PO
Pharmacological Study: Correlative studies
|
Group VI (Ruxolitinib)
Patients receive ruxolitinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Ruxolitinib: Given PO
|
Group VII (Idelalisib)
Patients receive idelalisib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Idelalisib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|---|---|---|---|---|---|
|
Progression-free Survival
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the date of subject registration to death, regardless of causes of death, assessed up to 3 yearsPopulation: Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
Kaplan-Meier method will be used to estimate the survival curve.
Outcome measures
| Measure |
Group I (Dasatinib)
n=4 Participants
Patients receive dasatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Dasatinib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
Group II (Sutinib Malate)
n=2 Participants
Patients receive sutinib malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Sunitinib: Given PO
Sunitinib Malate: Given PO
|
Group III (Sorafenib Tosylate)
n=6 Participants
Patients receive sorafenib tosylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Sorafenib: Given PO
Sorafenib Tosylate: Given PO
|
Group IV (Ponatinib Hydrochloride)
Patients receive ponatinib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Ponatinib: Given PO
Ponatinib Hydrochloride: Given PO
|
Group V (Pacritinib)
Patients receive pacritinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pacritinib: Given PO
Pharmacological Study: Correlative studies
|
Group VI (Ruxolitinib)
Patients receive ruxolitinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Ruxolitinib: Given PO
|
Group VII (Idelalisib)
Patients receive idelalisib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Idelalisib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|---|---|---|---|---|---|
|
Overall Survival
|
57 Days
Interval 18.0 to 147.0
|
75 Days
Interval 6.0 to 144.0
|
130 Days
Interval 43.0 to 430.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
Will be defined as a decrease of at least 25% in bone marrow blast counts or in peripheral blood blasts in subjects who have failed the initial inhibitor but are then treated with another inhibitor identified on repeat pre-clinical activity testing. The proportion of patients achieving the endpoint along with its 95% exact binomial confidence interval will be presented.
Outcome measures
| Measure |
Group I (Dasatinib)
n=4 Participants
Patients receive dasatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Dasatinib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
Group II (Sutinib Malate)
n=2 Participants
Patients receive sutinib malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Sunitinib: Given PO
Sunitinib Malate: Given PO
|
Group III (Sorafenib Tosylate)
n=6 Participants
Patients receive sorafenib tosylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Sorafenib: Given PO
Sorafenib Tosylate: Given PO
|
Group IV (Ponatinib Hydrochloride)
Patients receive ponatinib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Ponatinib: Given PO
Ponatinib Hydrochloride: Given PO
|
Group V (Pacritinib)
Patients receive pacritinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pacritinib: Given PO
Pharmacological Study: Correlative studies
|
Group VI (Ruxolitinib)
Patients receive ruxolitinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Ruxolitinib: Given PO
|
Group VII (Idelalisib)
Patients receive idelalisib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Idelalisib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|---|---|---|---|---|---|
|
Clinical Activity
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsPopulation: Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
Presence of active/aberrant kinase pathways will be determined using a small molecule kinase inhibitor screen, to rapidly identify therapeutic tyrosine kinase targets in leukemia patients while simultaneously providing individualized therapeutic options. Will be correlated with treatment response, mutational analysis using next generation sequencing, and characterization of aberrant gene expression in primary leukemia samples.
Outcome measures
| Measure |
Group I (Dasatinib)
n=4 Participants
Patients receive dasatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Dasatinib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
Group II (Sutinib Malate)
n=2 Participants
Patients receive sutinib malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Sunitinib: Given PO
Sunitinib Malate: Given PO
|
Group III (Sorafenib Tosylate)
n=6 Participants
Patients receive sorafenib tosylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Sorafenib: Given PO
Sorafenib Tosylate: Given PO
|
Group IV (Ponatinib Hydrochloride)
Patients receive ponatinib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Ponatinib: Given PO
Ponatinib Hydrochloride: Given PO
|
Group V (Pacritinib)
Patients receive pacritinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pacritinib: Given PO
Pharmacological Study: Correlative studies
|
Group VI (Ruxolitinib)
Patients receive ruxolitinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Ruxolitinib: Given PO
|
Group VII (Idelalisib)
Patients receive idelalisib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Idelalisib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|---|---|---|---|---|---|
|
Presence of Active/Aberrant Kinase Pathways
|
4 Participants
|
2 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Group I (Dasatinib)
Group II (Sunitinib Malate)
Group III (Sorafenib Tosylate)
Group IV (Ponatinib Hydrochloride)
Group V (Pacritinib)
Group VI (Ruxolitinib)
Group VII (Idelalisib)
Serious adverse events
| Measure |
Group I (Dasatinib)
n=4 participants at risk
Patients receive dasatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Dasatinib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
Group II (Sunitinib Malate)
n=2 participants at risk
Patients receive sutinib malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Sunitinib: Given PO
Sunitinib Malate: Given PO
|
Group III (Sorafenib Tosylate)
n=6 participants at risk
Patients receive sorafenib tosylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Sorafenib: Given PO
Sorafenib Tosylate: Given PO
|
Group IV (Ponatinib Hydrochloride)
Patients receive ponatinib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Ponatinib: Given PO
Ponatinib Hydrochloride: Given PO
|
Group V (Pacritinib)
Patients receive pacritinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pacritinib: Given PO
Pharmacological Study: Correlative studies
|
Group VI (Ruxolitinib)
Patients receive ruxolitinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Ruxolitinib: Given PO
|
Group VII (Idelalisib)
Patients receive idelalisib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Idelalisib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
50.0%
2/4 • Number of events 2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/6 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
0.00%
0/4 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
16.7%
1/6 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/4 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
16.7%
1/6 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/4 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
16.7%
1/6 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Investigations
Febrile neutropenia
|
0.00%
0/4 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
66.7%
4/6 • Number of events 5 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Metabolism and nutrition disorders
Hypoalbumenia
|
0.00%
0/4 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
16.7%
1/6 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Metabolism and nutrition disorders
Lipase increased
|
0.00%
0/4 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
16.7%
1/6 • Number of events 2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
1/4 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/6 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Infections and infestations
Sepsis
|
25.0%
1/4 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/6 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
16.7%
1/6 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
16.7%
1/6 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
Other adverse events
| Measure |
Group I (Dasatinib)
n=4 participants at risk
Patients receive dasatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Dasatinib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
Group II (Sunitinib Malate)
n=2 participants at risk
Patients receive sutinib malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Sunitinib: Given PO
Sunitinib Malate: Given PO
|
Group III (Sorafenib Tosylate)
n=6 participants at risk
Patients receive sorafenib tosylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Sorafenib: Given PO
Sorafenib Tosylate: Given PO
|
Group IV (Ponatinib Hydrochloride)
Patients receive ponatinib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Ponatinib: Given PO
Ponatinib Hydrochloride: Given PO
|
Group V (Pacritinib)
Patients receive pacritinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pacritinib: Given PO
Pharmacological Study: Correlative studies
|
Group VI (Ruxolitinib)
Patients receive ruxolitinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Ruxolitinib: Given PO
|
Group VII (Idelalisib)
Patients receive idelalisib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening
Idelalisib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
16.7%
1/6 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
25.0%
1/4 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/6 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/4 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
33.3%
2/6 • Number of events 2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Immune system disorders
Arthritis
|
0.00%
0/4 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
16.7%
1/6 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Blood and lymphatic system disorders
Hyperleukocytosis
|
25.0%
1/4 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/6 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Blood and lymphatic system disorders
Blood bilirubin increased
|
25.0%
1/4 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/6 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial infection
|
25.0%
1/4 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/6 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Cardiac disorders
Short of breath
|
25.0%
1/4 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/6 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Cardiac disorders
Tachycardia
|
25.0%
1/4 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/6 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Cardiac disorders
Troponemia
|
25.0%
1/4 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/6 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Metabolism and nutrition disorders
Creatinine increased
|
25.0%
1/4 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/6 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/6 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Cardiac disorders
Dyspnea
|
0.00%
0/4 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
16.7%
1/6 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Endocrine disorders
Elevated LFTs
|
25.0%
1/4 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/6 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Cardiac disorders
Hypertension
|
0.00%
0/4 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
16.7%
1/6 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
25.0%
1/4 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/6 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/4 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
16.7%
1/6 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/4 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
16.7%
1/6 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Infections and infestations
Influenza
|
25.0%
1/4 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/6 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
0.00%
0/4 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
33.3%
2/6 • Number of events 2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/4 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
16.7%
1/6 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
16.7%
1/6 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
0.00%
0/4 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
33.3%
2/6 • Number of events 2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
0.00%
0/4 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
33.3%
2/6 • Number of events 2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
25.0%
1/4 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/6 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
16.7%
1/6 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
0.00%
0/4 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
0.00%
0/2 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
16.7%
1/6 • Number of events 1 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
—
0/0 • Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place