Trial · NCT00363649

Interferon and GM-CSF Compared With Imatinib Mesylate and Vaccine Therapy in Patients With Chronic Phase CML on a TKI

NCT00363649, Phase 2, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; results first posted 2018-11-13

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Interferon and GM-CSF Compared With Imatinib Mesylate and Vaccine Therapy in Patients With Chronic Phase CML on a TKI. Trials, record NCT00363649. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00363649

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Trial

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

Title: Interferon and GM-CSF Compared With Imatinib Mesylate and Vaccine Therapy in Patients With Chronic Phase CML on a TKI
NCT number: NCT00363649
Status: Completed
Phases: Phase 2
Enrollment: 36 participants, actual
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions: Leukemia
Interventions: GM-K562 cell vaccine, Interferon alfa, Sargramostim
First posted: 2006-08-15
Last updated: 2018-11-13
Results first posted: 2018-11-13

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Progression-free Survival	1 year after treatment has been stopped	Number of patients alive and without disease progression or relapse
Primary	Complete Remission Rate	Up to 18 months	Percentage of patients who achieved molecular remission as defined by polymerase chain reaction negativity.
Secondary	Time to Complete Molecular Remission	Up to 27 months	Number of months from randomization to molecular remission as defined by polymerase chain reaction negativity.
Secondary	Disease-free Survival	Up to 8 years	Median number of days to progression of disease in participants who stopped all treatment as directed by the protocol.
Secondary	Early Discontinuation	1 year	Number of participants unable to complete protocol-specified treatment due to toxicity.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-free Survival	1 year after treatment has been stopped	Crossover participants were not analyzed for this outcome. This is as per the analysis plan written in this protocol.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Complete Remission Rate	Up to 18 months	Crossover participants were not analyzed for this outcome. This is as per the analysis plan written in this protocol.	percentage of participants	NUMBER
SECONDARY	Time to Complete Molecular Remission	Up to 27 months	Crossover participants were not analyzed for this outcome. This is as per the analysis plan written in this protocol.	months	MEDIAN
SECONDARY	Disease-free Survival	Up to 8 years	Crossover participants were not analyzed for this outcome. This is as per the analysis plan written in this protocol.	days	MEDIAN
SECONDARY	Early Discontinuation	1 year	This outcome includes all participants who were either started on an arm or crossed over to an arm.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Value	Spread	Units
Progression-free Survival	Arm A	2		Participants
Progression-free Survival	Arm B	0		Participants
Complete Remission Rate	Arm A	61.1		percentage of participants
Complete Remission Rate	Arm B	62.5		percentage of participants
Time to Complete Molecular Remission	Arm A	10	95% Confidence Interval 4.7 to 11.2	months
Time to Complete Molecular Remission	Arm B	16.3	95% Confidence Interval 6.9 to 27	months
Disease-free Survival	Arm A	82	Full Range 28 to 2924	days
Disease-free Survival	Arm B	98	Full Range 56 to 116	days
Early Discontinuation	Arm A	10		Participants
Early Discontinuation	Arm B	0		Participants

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm A	18
Overall Study	STARTED	Arm B	16
Overall Study	Crossed Over to Arm B	Arm A	9
Overall Study	Crossed Over to Arm B	Arm B	0
Overall Study	Crossed Over to Arm A	Arm A	0
Overall Study	Crossed Over to Arm A	Arm B	12
Overall Study	Did Not Cross Over	Arm A	2
Overall Study	Did Not Cross Over	Arm B	3
Overall Study	COMPLETED	Arm A	11
Overall Study	COMPLETED	Arm B	15

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events150

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	Acid reflux	Gastrointestinal disorders	Arm A	1	30	1
other	Acid reflux	Gastrointestinal disorders	Arm B	3	25	4
other	Adenopathy	Immune system disorders	Arm A	5	30	5
other	Adenopathy	Immune system disorders	Arm B	3	25	4
other	Allergic reaction	Immune system disorders	Arm A	1	30	1
other	Allergic reaction	Immune system disorders	Arm B	1	25	2
other	Alopecia	General disorders	Arm A	4	30	4
other	Alopecia	General disorders	Arm B	3	25	3
other	ALT increased	Investigations	Arm A	8	30	17
other	ALT increased	Investigations	Arm B	3	25	5

1 to 10 of 150Source ClinicalTrials.gov

See all 150 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A	0	30
Total, all-cause mortality	Arm B	0	25
Total, other adverse events	Arm A	30	30
Total, other adverse events	Arm B	25	25
Total, serious adverse events	Arm A	2	30
Total, serious adverse events	Arm B	0	25

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
P30CA006973	Regional Oncology Research Center	NELSON, WILLIAM GEORGE	JOHNS HOPKINS UNIVERSITY	NATIONAL CANCER INSTITUTE	1985 to 2025

Source NIH RePORTER

Trial comparisons4

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

Comparison	Source
Arm A vs Arm B: Progression-free Survival	Trial comparisons
Arm A vs Arm B: deaths from any cause	Trial comparisons
Arm A vs Arm B: Early Discontinuation	Trial comparisons
Arm A vs Arm B: 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/NCT00363649

GET https://conductscience.org/api/trials/v1/NCT00363649/events?page=2

API reference For AI assistants