Trial · NCT00070499

Imatinib Mesylate or Dasatinib in Treating Patients With Previously Untreated Chronic Phase Chronic Myelogenous Leukemia

NCT00070499, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2012-07-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Imatinib Mesylate or Dasatinib in Treating Patients With Previously Untreated Chronic Phase Chronic Myelogenous Leukemia. Trials, record NCT00070499. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00070499

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Trial

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

Title: Imatinib Mesylate or Dasatinib in Treating Patients With Previously Untreated Chronic Phase Chronic Myelogenous Leukemia
NCT number: NCT00070499
Status: Active not recruiting
Phases: Phase 2
Enrollment: 406 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Chronic Myeloid Leukemia, BCR-ABL1 Positive
Interventions: Dasatinib, Imatinib Mesylate, Laboratory Biomarker Analysis
First posted: 2003-10-07
Last updated: 2026-08-26
Results first posted: 2012-07-10

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Molecular Response Rate at 12 Months	pretreatment and after 12 months of treatment	Median value of baseline bcr-abl/bcr ratio from pretreatment was used as the baseline value for assessing each patient's molecular response. Molecular response criteria were: 1) not failed treatment on or before 12-month evaluation; 2) met criteria for hemalotogic response; 3) bcr-abl/bcr ration at 12-months must be 10,000 times smaller than the pretreatment ratio.
Secondary	Hematologic Response	1 month after starting treatment	Hematologic response assesses whether patients' blood counts return to normal
Secondary	2-year Overall Survival (OS)	Every three months for the first year, every six months in years 2 and 3, and annually for years 4 and 5	Overall survival was measured from the date of registration to study until death from any cause with observations censored at the date of last contact for patients last known to be alive.
Secondary	Two Year Relapse-free Survival	every 3 months for the first year, every six months for years 2 and 3, annually for years 4 and 5	Relapse-free survival is measured from the date of documented (possibly unconfirmed) hematologic complete remission until loss of hematologic complete remission or death from any cause. Observations are censored at the date of last contact for patients last known to be alive with report of loss of hematologic complete remission.
Secondary	Toxicity	Patients were assessed for adverse events monthly every 4 weeks for the first year, every 6 months for years 2 and 3, and annually for years 4 and 5.	Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event

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	Molecular Response Rate at 12 Months	pretreatment and after 12 months of treatment	Patients with follow-up specimens assayed by reverse transcription polymerase chain reaction (RT-PCR)	participants	NUMBER
SECONDARY	Hematologic Response	1 month after starting treatment	Eligible, treated patients who were evaluable for hematologic response	participants	NUMBER
SECONDARY	2-year Overall Survival (OS)	Every three months for the first year, every six months in years 2 and 3, and annually for years 4 and 5	All eligible patients who were treated	Percent of population	NUMBER
SECONDARY	Two Year Relapse-free Survival	every 3 months for the first year, every six months for years 2 and 3, annually for years 4 and 5	Eligible, treated patients who achieved a hematologic complete remission	Percent of population	NUMBER
SECONDARY	Toxicity	Patients were assessed for adverse events monthly every 4 weeks for the first year, every 6 months for years 2 and 3, and annually for years 4 and 5.	Eligible patients who started therapy	Participants with a given type of AE	NUMBER

Source ClinicalTrials.gov

Results by group328

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

Outcome	Group	Value	Units
Molecular Response Rate at 12 Months	Standard Dose Imatinib A	5	participants
Molecular Response Rate at 12 Months	High Dose Imatinib	14	participants
Molecular Response Rate at 12 Months	Dasatinib	27	participants
Molecular Response Rate at 12 Months	Standard Dose Imatinib B	18	participants
Hematologic Response	Standard Dose Imatinib A	63	participants
Hematologic Response	High Dose Imatinib	66	participants
Hematologic Response	Dasatinib	107	participants
Hematologic Response	Standard Dose Imatinib B	112	participants
2-year Overall Survival (OS)	Standard Dose Imatinib A	89	Percent of population
2-year Overall Survival (OS)	High Dose Imatinib	95	Percent of population

1 to 10 of 328Source ClinicalTrials.gov

See all 328 results by group

Participant flow20

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Standard Dose Imatinib A	75
Overall Study	STARTED	High Dose Imatinib	78
Overall Study	STARTED	Dasatinib	126
Overall Study	STARTED	Standard Dose Imatinib B	127
Overall Study	Eligible	Standard Dose Imatinib A	73
Overall Study	Eligible	High Dose Imatinib	73
Overall Study	Eligible	Dasatinib	123
Overall Study	Eligible	Standard Dose Imatinib B	125
Overall Study	Eligible and Treated	Standard Dose Imatinib A	72
Overall Study	Eligible and Treated	High Dose Imatinib	73

1 to 10 of 20Source ClinicalTrials.gov

See all 20 participant flow

Adverse events380

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	Hemoglobin	Blood and lymphatic system disorders	Standard Dose Imatinib A	47	72	47
other	Hemoglobin	Blood and lymphatic system disorders	High Dose Imatinib	59	72	59
other	Hemoglobin	Blood and lymphatic system disorders	Dasatinib	86	122	86
other	Hemoglobin	Blood and lymphatic system disorders	Standard Dose Imatinib B	87	123	87
other	Vision-blurred vision	Eye disorders	Standard Dose Imatinib A	5	72	5
other	Vision-blurred vision	Eye disorders	High Dose Imatinib	4	72	4
other	Vision-blurred vision	Eye disorders	Dasatinib	0	122	0
other	Vision-blurred vision	Eye disorders	Standard Dose Imatinib B	7	123	7
other	Watery eye (epiphora, tearing)	Eye disorders	Standard Dose Imatinib A	0	72	0
other	Watery eye (epiphora, tearing)	Eye disorders	High Dose Imatinib	10	72	10

1 to 10 of 380Source ClinicalTrials.gov

See all 380 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Standard Dose Imatinib A
Total, all-cause mortality	High Dose Imatinib
Total, all-cause mortality	Dasatinib
Total, all-cause mortality	Standard Dose Imatinib B
Total, other adverse events	Standard Dose Imatinib A	71	72
Total, other adverse events	High Dose Imatinib	72	72
Total, other adverse events	Dasatinib	115	122
Total, other adverse events	Standard Dose Imatinib B	120	123
Total, serious adverse events	Standard Dose Imatinib A	4	72
Total, serious adverse events	High Dose Imatinib	0	72

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22915637	DERIVED

Source PubMed

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
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	NIH RePORTER
U10CA032102	Southwest Oncology Group Treatment Grant	BLANKE, CHARLES D.	OREGON HEALTH & SCIENCE UNIVERSITY	NATIONAL CANCER INSTITUTE	1985 to 2013	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.

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