NCT01620216 · OUTCOME

Clinical Activity

Targeted Therapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia · Source last updated 2021-11-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Up to 28 days

What was measured

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.

Analysis population: Zero patients enrolled in Ponatinib, Pacrtitinib, Ruxolitinib, and Idealisib arms.

Groups in this outcome

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Group I (Dasatinib)	4
Group II (Sutinib Malate)	2
Group III (Sorafenib Tosylate)	6
Group IV (Ponatinib Hydrochloride)	0
Group V (Pacritinib)	0
Group VI (Ruxolitinib)	0
Group VII (Idelalisib)	0

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Group I (Dasatinib)	1	Not reported	Not reported	Not reported	Not reported
Group II (Sutinib Malate)	0	Not reported	Not reported	Not reported	Not reported
Group III (Sorafenib Tosylate)	4	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
4

denoms

counts
group Id
OG000
value
4
group Id
OG001
value
2
group Id
OG002
value
6
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
units
Participants

description

groups

description
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
id
OG000
title
Group I (Dasatinib)
description
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
id
OG001
title
Group II (Sutinib Malate)
description
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
id
OG002
title
Group III (Sorafenib Tosylate)
description
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
id
OG003
title
Group IV (Ponatinib Hydrochloride)
description
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
id
OG004
title
Group V (Pacritinib)
description
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
id
OG005
title
Group VI (Ruxolitinib)
description
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
id
OG006
title
Group VII (Idelalisib)

param Type

COUNT_OF_PARTICIPANTS

population Description

Zero patients enrolled in Ponatinib, Pacrtitinib, Ruxolitinib, and Idealisib arms.

reporting Status

POSTED

time Frame

Up to 28 days

title

Clinical Activity

type

PRIMARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice