NCT01620216 · OUTCOME

Overall Objective Response Rates (Complete and Partial)

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 3 years

What was measured

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.

Analysis population: Zero patients enrolled in Ponatinib, Pacritinib, 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

Partial response

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Group I (Dasatinib)	0	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)	1	Not reported	Not reported	Not reported	Not reported

Progressive disease

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Group I (Dasatinib)	2	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)	0	Not reported	Not reported	Not reported	Not reported

Stable disease

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Group I (Dasatinib)	2	Not reported	Not reported	Not reported	Not reported
Group II (Sutinib Malate)	2	Not reported	Not reported	Not reported	Not reported
Group III (Sorafenib Tosylate)	4	Not reported	Not reported	Not reported	Not reported

Not assessable

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Group I (Dasatinib)	0	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)	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
title
Partial response
measurements
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
0
title
Progressive disease
measurements
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
4
title
Stable disease
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
title
Not assessable

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, Pacritinib, Ruxolitinib, and Idealisib arms.

reporting Status

POSTED

time Frame

Up to 3 years

title

Overall Objective Response Rates (Complete and Partial)

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice