Trial · NCT02513498

Ixazomib Citrate in Treating Patients With Chronic Graft-versus-Host Disease

NCT02513498, Phase 2, Completed, Fred Hutchinson Cancer Center; results first posted 2019-02-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Ixazomib Citrate in Treating Patients With Chronic Graft-versus-Host Disease. Trials, record NCT02513498. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02513498

On this page

Trial

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

Title: Ixazomib Citrate in Treating Patients With Chronic Graft-versus-Host Disease
NCT number: NCT02513498
Status: Completed
Phases: Phase 2
Enrollment: 50 participants, actual
Lead sponsor: Fred Hutchinson Cancer Center
Conditions: Chronic Graft Versus Host Disease
Interventions: Ixazomib Citrate, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration
First posted: 2015-07-31
Last updated: 2019-02-06
Results first posted: 2019-02-06

Source ClinicalTrials.gov

Registered outcomes16

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

List	Outcome	Time frame	Description
Primary	Incidence of Adverse Events	Up to 30 days following completion of study treatment	According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0
Primary	Probability of Treatment Failure at 6 Months	6 months	Kaplan-Meier estimate assessed at 6 months for probability of treatment failure, defined as addition of a line of systemic immune-suppressive therapy, recurrent malignancy, or death.
Secondary	Biologic Studies	Up to 6 months	The biologic impact of proteasome inhibition in the treatment of chronic GVHD will be assessed.
Secondary	Complete Response (CR) Rate	6 months	Response will be determined by both clinician-defined, as well as separately calculated according to the proposed response definitions of the NIH Consensus Conference.
Secondary	Probability of Non-relapse Mortality at 1 Year	1 year	Kaplan-Meier estimate assessed at 1 year for probability of non-relapse mortality, defined as death in the absence of primary malignancy relapse after transplant.
Secondary	Cumulative Incidence of Primary Malignancy Relapse	1 year	Defined as hematologic relapse or any unplanned intervention to prevent progression of disease in patients with evidence (molecular, cytogenetic, flow cytometric, radiographic) of malignant disease after transplantation.
Secondary	Probability of Failure-free Survival at 1 Year	1 year	Kaplan-Meier estimate assessed at 1 year for failure-free survival, defined as the absence of death from any cause, relapse or addition of secondary immune suppressive agents.
Secondary	Incidence of Discontinuation of All Systemic Immune Suppressive Therapies	1 year	The incidence of complete discontinuation of all systemic immune-suppressive therapies will be determined at 1 year.
Secondary	Overall Response Rate (ORR) (Complete Response + Partial Response)	6 months	ORR at 6 months will be determined by both clinician-defined categories of complete response and partial response, as well as separately calculated according to the proposed response definitions of the NIH Consensus Conference.
Secondary	Probability of Overall Survival at 1 Year	1 year	Kaplan-Meier estimate assessed at 1 year for overall survival, defined as absence of death from any cause.

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Incidence of Adverse Events	Up to 30 days following completion of study treatment		participants	NUMBER
PRIMARY	Probability of Treatment Failure at 6 Months	6 months		Treatment failure probability	NUMBER
SECONDARY	Biologic Studies	Up to 6 months	Response to study drug too minimal to justify time and expense to perform biologic studies.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Complete Response (CR) Rate	6 months	Participants who could be evaluated for response (not missing data)	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Probability of Non-relapse Mortality at 1 Year	1 year		non-relapse mortality probability	NUMBER
SECONDARY	Cumulative Incidence of Primary Malignancy Relapse	1 year		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Probability of Failure-free Survival at 1 Year	1 year		probability of failure-free survival	NUMBER
SECONDARY	Incidence of Discontinuation of All Systemic Immune Suppressive Therapies	1 year		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Overall Response Rate (ORR) (Complete Response + Partial Response)	6 months	Participants with missing response data are counted as failures; primarily missing due to failure to collect data in patients who stopped study drug but did not experience treatment failure.	participants	NUMBER
SECONDARY	Probability of Overall Survival at 1 Year	1 year		probability of overall survival	NUMBER

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group52

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

Outcome	Group	Category	Value	Units
Incidence of Adverse Events	Treatment (Ixazomib Citrate)	Serious Adverse Events	19	participants
Incidence of Adverse Events	Treatment (Ixazomib Citrate)	Non-Serious Adverse Events	18	participants
Probability of Treatment Failure at 6 Months	Treatment (Ixazomib Citrate)		.28	Treatment failure probability
Biologic Studies	Treatment (Ixazomib Citrate)		0	Participants
Complete Response (CR) Rate	Response Evaluated by MD	Partial Response	16	Participants
Complete Response (CR) Rate	Response Evaluated by NIH	Partial Response	17	Participants
Complete Response (CR) Rate	Response Evaluated by MD	Mixed Response	4	Participants
Complete Response (CR) Rate	Response Evaluated by NIH	Mixed Response	10	Participants
Complete Response (CR) Rate	Response Evaluated by MD	Unchanged	9	Participants
Complete Response (CR) Rate	Response Evaluated by NIH	Unchanged	4	Participants

1 to 10 of 52Source ClinicalTrials.gov

See all 52 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Treatment (Ixazomib Citrate)	50
Overall Study	COMPLETED	Treatment (Ixazomib Citrate)	26
Overall Study	NOT COMPLETED	Treatment (Ixazomib Citrate)	24

Source ClinicalTrials.gov

Adverse events47

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	amylase increased	Investigations	Treatment (Ixazomib Citrate)	1	50	1
other	constipation	Gastrointestinal disorders	Treatment (Ixazomib Citrate)	1	50	1
other	diarrhea	Gastrointestinal disorders	Treatment (Ixazomib Citrate)	1	50	1
other	fatigue	General disorders	Treatment (Ixazomib Citrate)	1	50	1
other	headache	Nervous system disorders	Treatment (Ixazomib Citrate)	1	50	1
other	hyperglycemia	Metabolism and nutrition disorders	Treatment (Ixazomib Citrate)	1	50	1
other	hypertriglyceridemia	Metabolism and nutrition disorders	Treatment (Ixazomib Citrate)	2	50	3
other	hyponatremia	Metabolism and nutrition disorders	Treatment (Ixazomib Citrate)	1	50	1
other	hypophosphatemia	Metabolism and nutrition disorders	Treatment (Ixazomib Citrate)	1	50	1
other	influenza a	Infections and infestations	Treatment (Ixazomib Citrate)	1	50	1

1 to 10 of 47Source ClinicalTrials.gov

See all 47 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment (Ixazomib Citrate)	5	50
Total, other adverse events	Treatment (Ixazomib Citrate)	18	50
Total, serious adverse events	Treatment (Ixazomib Citrate)	19	50

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

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
P30CA015704	Cancer Center Support Grant	LYNCH, THOMAS JAMES	FRED HUTCHINSON CANCER CENTER	NATIONAL CANCER INSTITUTE	1985 to 2025

Source 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.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license 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/NCT02513498

GET https://conductscience.org/api/trials/v1/NCT02513498/results?page=2

API reference For AI assistants