Trial · NCT02572453

Phase 2 Study of AT13387 (Onalespib) in ALK+ ALCL, MCL, and BCL-6+ DLBCL

NCT02572453, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2022-09-13

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. Phase 2 Study of AT13387 (Onalespib) in ALK+ ALCL, MCL, and BCL-6+ DLBCL. Trials, record NCT02572453. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02572453

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phase 2 Study of AT13387 (Onalespib) in ALK+ ALCL, MCL, and BCL-6+ DLBCL
NCT number: NCT02572453
Status: Terminated
Phases: Phase 2
Enrollment: 25 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Recurrent Anaplastic Large Cell Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Transformed Non-Hodgkin Lymphoma, Refractory Anaplastic Large Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Refractory Mantle Cell Lymphoma, Refractory Transformed Non-Hodgkin Lymphoma
Interventions: Onalespib
First posted: 2015-10-09
Last updated: 2022-09-13
Results first posted: 2022-09-13

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Objective Response Rate	Assessed every 2 cycles during treatment until disease progression; patients who discontinue for reasons other than progression will be evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy	Objective response (OR) = Complete + Partial (CR + PR) Per International Harmonization Project for lymphoma criteria, CR is defined as the disappearance of all evidence of disease. For FDG-avid or PET positive sites of disease prior to therapy, a mass of any size is permitted if PET negative; for variably FDG avid or PET negative lesions, regression to normal size on CT is necessary. The spleen or liver must also be nonpalpable with disappearance of any nodules, and the bone marrow, if initially involved, must be cleared on repeat biopsy. PR is defined as regression of measurable disease and no new sites of disease: a \>50% decrease in the sum of the diameters of the up to 6 largest dominant masses with no increase in size of other masses. If the sites of disease were PET positive at baseline, there must be at least one previously involved site that remains PET positive.
Secondary	Frequency of Toxicities	Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy	Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (version 5.0 is used staring April 1, 2018). Toxicities will be summarized with counts and proportions within each cohort and overall.
Secondary	Progression-free Survival	From the date of study entry until documentation of first progression or death from any cause; progression assessed every 2 cycles during treatment until disease progression or death	The progression-free survival will be estimated by Kaplan-Meier method. Progressive disease is defined by the International Harmonization Project for lymphoma criteria: any new lesion or an increase by \> 50% of previously involved sites from nadir. This includes the appearance of any new lesion(s) \> 1.5cm in any axis, a \> 50% increase in the sum of diameters of \> 1 site of disease or \> 50% increase in the longest diameter of a previously identified node \>1cm in short axis. If the sites of disease were PET positive at baseline, they must remain PET positive.
Secondary	Overall Survival	From the date of study entry until death from any cause; assessed every 6 months for up to 1 year after ending treatment	The overall survival will be estimated by Kaplan-Meier method. Median follow-up time will be assessed using the reverse Kaplan-Meier method.
Secondary	Duration of Response	From first objective response (partial response or complete response) until the first date of documented progression assessed every 2 cycles or death due to any cause; assessed every 6 months up to 1 year after ending treatment	Duration of response will be evaluated only in patients who respond with either a partial response or complete response while on study.
Other	Change in Protein Levels of BCL6 in Diffuse Large B Cell Lymphoma	Assessed days 1, 8, 15 of each 28-day cycle and at treatment completion visit	Will be assessed via immunohistochemistry. Comparisons will be made between baseline, on treatment, and time of progression protein levels and changes will be characterized as differences and as differences at the referenced time point as a proportion of baseline levels. An H-score will be used. The Wilcoxon rank sum test will be used to compare changes between responders and non-responders and a one-sided significance level will be used.
Other	Change in Protein Levels of Cyclin D1 in Mantle Cell Lymphoma	Assessed days 1, 8, 15 of each 28-day cycle and at treatment completion visit	Will be assessed via immunohistochemistry. Comparisons will be made between baseline, on treatment, and time of progression protein levels and changes will be characterized as differences and as differences at the referenced time point as a proportion of baseline levels. An H-score will be used. The Wilcoxon rank sum test will be used to compare changes between responders and non-responders and a one-sided significance level will be used.
Other	Change in Protein Levels of ALK in ALK+ Anaplastic Large Cell Lymphoma	Assessed days 1, 8, 15 of each 28-day cycle and at treatment completion visit	Will be assessed via immunohistochemistry. Comparisons will be made between baseline, on treatment, and time of progression protein levels. An H-score will be used. Results at each time point and as changes as a proportion of baseline levels will be reported descriptively.
Other	Onalespib Activity	Assessed days 1, 8, 15 of each 28-day cycle and at treatment completion visit	Will be measured by changes in protein levels via immunoblotting. Will use a one-sided significance level.
Other	Genetic and Transcriptional Analysis for Markers of Response and Resistance	Assessed days 1, 8, 15 of each 28-day cycle and at treatment completion visit	Will be assessed via exome sequencing and ribonucleic acid sequencing. Absolute algorithm will be used to determine the cancer cell fraction.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Objective Response Rate	Assessed every 2 cycles during treatment until disease progression; patients who discontinue for reasons other than progression will be evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Frequency of Toxicities	Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy	All patients who received any amount of study treatment	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Progression-free Survival	From the date of study entry until documentation of first progression or death from any cause; progression assessed every 2 cycles during treatment until disease progression or death		months	MEDIAN
SECONDARY	Overall Survival	From the date of study entry until death from any cause; assessed every 6 months for up to 1 year after ending treatment		months	MEDIAN
SECONDARY	Duration of Response	From first objective response (partial response or complete response) until the first date of documented progression assessed every 2 cycles or death due to any cause; assessed every 6 months up to 1 year after ending treatment	Patients who achieved partial or complete response, n=2 of 25	months	MEDIAN
OTHER_PRE_SPECIFIED	Change in Protein Levels of BCL6 in Diffuse Large B Cell Lymphoma	Assessed days 1, 8, 15 of each 28-day cycle and at treatment completion visit
OTHER_PRE_SPECIFIED	Change in Protein Levels of Cyclin D1 in Mantle Cell Lymphoma	Assessed days 1, 8, 15 of each 28-day cycle and at treatment completion visit
OTHER_PRE_SPECIFIED	Change in Protein Levels of ALK in ALK+ Anaplastic Large Cell Lymphoma	Assessed days 1, 8, 15 of each 28-day cycle and at treatment completion visit
OTHER_PRE_SPECIFIED	Onalespib Activity	Assessed days 1, 8, 15 of each 28-day cycle and at treatment completion visit
OTHER_PRE_SPECIFIED	Genetic and Transcriptional Analysis for Markers of Response and Resistance	Assessed days 1, 8, 15 of each 28-day cycle and at treatment completion visit

Source ClinicalTrials.gov

Results by group25

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Objective Response Rate	ALK+ ALCL		0	Participants
Objective Response Rate	Relapsed MCL		0	Participants
Objective Response Rate	BCL6+ DLBCL		2	Participants
Frequency of Toxicities	ALK+ ALCL	Any grade	1	Participants
Frequency of Toxicities	Relapsed MCL	Any grade	4	Participants
Frequency of Toxicities	BCL6+ DLBCL	Any grade	19	Participants
Frequency of Toxicities	ALK+ ALCL	Grade 1 (highest)	1	Participants
Frequency of Toxicities	Relapsed MCL	Grade 1 (highest)	1	Participants
Frequency of Toxicities	BCL6+ DLBCL	Grade 1 (highest)	1	Participants
Frequency of Toxicities	ALK+ ALCL	Grade 2 (highest)	0	Participants

1 to 10 of 25Source ClinicalTrials.gov

See all 25 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	ALK+ ALCL	1
Overall Study	STARTED	Relapsed MCL	4
Overall Study	STARTED	BCL6+ DLBCL	20
Overall Study	COMPLETED	ALK+ ALCL	1
Overall Study	COMPLETED	Relapsed MCL	4
Overall Study	COMPLETED	BCL6+ DLBCL	20
Overall Study	NOT COMPLETED	ALK+ ALCL	0
Overall Study	NOT COMPLETED	Relapsed MCL	0
Overall Study	NOT COMPLETED	BCL6+ DLBCL	0

Source ClinicalTrials.gov

Adverse events201

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhea	Gastrointestinal disorders	ALK+ ALCL	1	1	1
other	Diarrhea	Gastrointestinal disorders	Relapsed MCL	3	4	16
other	Diarrhea	Gastrointestinal disorders	BCL6+ DLBCL	13	20	36
other	Platelet count decreased	Investigations	ALK+ ALCL	0	1	0
other	Platelet count decreased	Investigations	Relapsed MCL	4	4	8
other	Platelet count decreased	Investigations	BCL6+ DLBCL	12	20	28
other	Nausea	Gastrointestinal disorders	ALK+ ALCL	0	1	0
other	Nausea	Gastrointestinal disorders	Relapsed MCL	3	4	4
other	Nausea	Gastrointestinal disorders	BCL6+ DLBCL	8	20	19
other	Lymphocyte count decreased	Investigations	ALK+ ALCL	0	1	0

1 to 10 of 201Source ClinicalTrials.gov

See all 201 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ALK+ ALCL	0	1
Total, all-cause mortality	Relapsed MCL	1	4
Total, all-cause mortality	BCL6+ DLBCL	13	20
Total, other adverse events	ALK+ ALCL	1	1
Total, other adverse events	Relapsed MCL	4	4
Total, other adverse events	BCL6+ DLBCL	19	20
Total, serious adverse events	ALK+ ALCL	0	1
Total, serious adverse events	Relapsed MCL	0	4
Total, serious adverse events	BCL6+ DLBCL	5	20

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
UM1CA186690	NCI ETCTN Pittsburgh Cancer Consortium (PCC)	VILLARUZ, LIZA COSCA; BYRD, JOHN C.; DAYYANI, FARSHID	UNIVERSITY OF PITTSBURGH AT PITTSBURGH	NATIONAL CANCER INSTITUTE	2014 to 2025	NIH RePORTER
UM1CA186709	Dana-Farber/Harvard Cancer Center Experimental Therapeutics Clinical Trials Network Site (DF/HCC ETCTN Site)	SHAPIRO, GEOFFREY I.; FLAHERTY, KEITH T; KUFE, DONALD W.	DANA-FARBER CANCER INST	NATIONAL CANCER INSTITUTE	2014 to 2025	NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02572453

GET https://conductscience.org/api/trials/v1/NCT02572453/results?page=2

API reference For AI assistants