Trial · NCT03654768

Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia

NCT03654768, Phase 2, Active not recruiting, SWOG Cancer Research Network; results first posted 2025-12-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia. Trials, record NCT03654768. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03654768

On this page

Trial

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

Title: Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia
NCT number: NCT03654768
Status: Active not recruiting
Phases: Phase 2
Enrollment: 81 participants, actual
Lead sponsor: SWOG Cancer Research Network
Conditions: Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Interventions: Bosutinib, Dasatinib, Laboratory Biomarker Analysis, Nilotinib, Ruxolitinib, Imatinib
First posted: 2018-08-31
Last updated: 2025-12-18
Results first posted: 2025-12-18

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Rate of Molecular Response 4.5 (MR4.5)	At 12 months	The participants BCR-ABL/BCR ratio must be at least 31,623 times (4.5 logs) smaller than100% IS, i.e., must demonstrate a 4.5-log reduction relative to 100% IS. When reported on the International Scale (IS), this response is equivalent to a value of ≤ 0.0032%. Values are reported as percentages with a higher rate being better then a lower rate.
Secondary	Overall Survival	From the date of randomization until death from any cause with observations censored at the date of last contact for patients last known to be alive, assessed up to 3 years	Overall survival will be measured for all patients from the date of randomization until death from any cause with observations censored at the date of last contact for patients last known to be alive. The results were presented as 3-year OS estimate.
Secondary	Progression-free Survival	From the date of randomization on study until the first of treatment failure/loss of response, progression, or death from any cause, assessed up to 5 years	Progression-free survival is measured from the date of randomization on study until the first of treatment failure/loss of response, progression, or death from any cause. Observations are censored at the date of last follow-up for patients last known to be alive without report of treatment failure/loss of response or progression.
Secondary	Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Duration of treatment and follow-up until death or 5 years post registration.	Only adverse events that are possibly, probably or definitely related to study drug are reported. CTCAE Version 5.0 was used for all AE reporting.
Secondary	MR4.5 Attainment	Up to 12 months	Will be summarized descriptively
Secondary	Molecular Rate 4.0 (MR 4.0) Attainment	Up to 12 months	Will be summarized descriptively
Secondary	Drug Compliance	Up to 5 years	Will be summarized descriptively, results presented as number of participants that were fully compliant for all cycles that they received treatment.
Secondary	BCR-ABL/BCR Comparison	Up to 5 years	Quantitative RT-PCR measurement of BCR-ABL transcript levels on the International Scale (IS), expressed as log₁₀ ratios of BCR-ABL to ABL. Mean and standard deviation of log₁₀ BCR-ABL (IS) are reported at 3, 6, 9, and 12 months for each treatment arm. Lower values represent deeper molecular response. This scale ranges from 0 to -5, with a more negative number corresponding to a better outcome.

Source ClinicalTrials.gov

Outcomes8

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Rate of Molecular Response 4.5 (MR4.5)	At 12 months	This population includes the 75 eligible and evaluable participants. 38 in the Single Agent TKI arm and 37 in the TKI + Ruxolitnib arm.	percentage of participants	NUMBER
SECONDARY	Overall Survival	From the date of randomization until death from any cause with observations censored at the date of last contact for patients last known to be alive, assessed up to 3 years	This population includes the 75 eligible and evaluable participants. 38 in the Single Agent TKI arm and 37 in the TKI + Ruxolitnib arm.	percentage of participants	NUMBER
SECONDARY	Progression-free Survival	From the date of randomization on study until the first of treatment failure/loss of response, progression, or death from any cause, assessed up to 5 years	This population includes the 75 eligible and evaluable participants. 38 in the Single Agent TKI arm and 37 in the TKI + Ruxolitnib arm.	percentage of participants	NUMBER
SECONDARY	Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Duration of treatment and follow-up until death or 5 years post registration.	Participants who were eligible and received at least one dose of protocol treatment.	Participants	NUMBER
SECONDARY	MR4.5 Attainment	Up to 12 months	This population includes the 75 eligible and evaluable participants. 38 in the Single Agent TKI arm and 37 in the TKI + Ruxolitnib arm.	percentage of participants	NUMBER
SECONDARY	Molecular Rate 4.0 (MR 4.0) Attainment	Up to 12 months	This population includes the 75 eligible and evaluable participants. 38 in the Single Agent TKI arm and 37 in the TKI + Ruxolitnib arm.	percentage of participants	NUMBER
SECONDARY	Drug Compliance	Up to 5 years	This population includes the 73 participants who were eligible and received at least one dose of study treatment. 37 in the Single Agent TKI arm and 36 in the TKI + Ruxolitnib arm.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	BCR-ABL/BCR Comparison	Up to 5 years	This population includes the 75 eligible and evaluable participants. 38 in the Single Agent TKI arm and 37 in the TKI + Ruxolitnib arm.	Log₁₀ BCR-ABL Ratio	MEAN

Source ClinicalTrials.gov

Results by group52

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

Outcome	Group	Category	Value	Spread	Units
Rate of Molecular Response 4.5 (MR4.5)	Single Agent TKI		3		percentage of participants
Rate of Molecular Response 4.5 (MR4.5)	TKI + Ruxolitinib		14		percentage of participants
Overall Survival	Single Agent TKI		100	95% Confidence Interval NA to NA	percentage of participants
Overall Survival	TKI + Ruxolitinib		97	95% Confidence Interval 80 to 100	percentage of participants
Progression-free Survival	Single Agent TKI		89	95% Confidence Interval 74 to 96	percentage of participants
Progression-free Survival	TKI + Ruxolitinib		89	95% Confidence Interval 73 to 96	percentage of participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Single Agent TKI	Constipation	0		Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	TKI + Ruxolitinib	Constipation	1		Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Single Agent TKI	Fatigue	0		Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	TKI + Ruxolitinib	Fatigue	1		Participants

1 to 10 of 52Source ClinicalTrials.gov

See all 52 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Single Agent TKI	38
Overall Study	STARTED	TKI + Ruxolitinib	37
Overall Study	COMPLETED	Single Agent TKI	33
Overall Study	COMPLETED	TKI + Ruxolitinib	22
Overall Study	NOT COMPLETED	Single Agent TKI	5
Overall Study	NOT COMPLETED	TKI + Ruxolitinib	15

Source ClinicalTrials.gov

Adverse events158

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
other	Anemia	Blood and lymphatic system disorders	Single Agent TKI	5	37
other	Anemia	Blood and lymphatic system disorders	TKI + Ruxolitinib	15	36
other	Palpitations	Cardiac disorders	Single Agent TKI	1	37
other	Palpitations	Cardiac disorders	TKI + Ruxolitinib	2	36
other	Tinnitus	Ear and labyrinth disorders	Single Agent TKI	2	37
other	Tinnitus	Ear and labyrinth disorders	TKI + Ruxolitinib	1	36
other	Abdominal pain	Gastrointestinal disorders	Single Agent TKI	1	37
other	Abdominal pain	Gastrointestinal disorders	TKI + Ruxolitinib	3	36
other	Constipation	Gastrointestinal disorders	Single Agent TKI	5	37
other	Constipation	Gastrointestinal disorders	TKI + Ruxolitinib	3	36

1 to 10 of 158Source ClinicalTrials.gov

See all 158 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Single Agent TKI	0	38
Total, all-cause mortality	TKI + Ruxolitinib	1	37
Total, other adverse events	Single Agent TKI	31	37
Total, other adverse events	TKI + Ruxolitinib	35	36
Total, serious adverse events	Single Agent TKI	0	37
Total, serious adverse events	TKI + Ruxolitinib	4	36

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33513367	DERIVED

Source PubMed

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
U10CA180888	SWOG Network Group Operations Center of the NCTN	LARA, PRIMO N.; HERSHMAN, DAWN	UNIVERSITY OF CALIFORNIA AT DAVIS	NATIONAL CANCER INSTITUTE	2014 to 2026

Source NIH RePORTER

Trial comparisons3

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

Comparison	Source
Single Agent TKI vs TKI + Ruxolitinib: Drug Compliance	Trial comparisons
Single Agent TKI vs TKI + Ruxolitinib: deaths from any cause	Trial comparisons
Single Agent TKI vs TKI + Ruxolitinib: serious adverse events	Trial comparisons

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/NCT03654768

GET https://conductscience.org/api/trials/v1/NCT03654768/results?page=2

API reference For AI assistants