Trial · NCT00085709

S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML

NCT00085709, Phase 3, Completed, SWOG Cancer Research Network; results first posted 2012-08-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML. Trials, record NCT00085709. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00085709

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Trial

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

Title: S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML
NCT number: NCT00085709
Status: Completed
Phases: Phase 3
Enrollment: 637 participants, actual
Lead sponsor: SWOG Cancer Research Network
Conditions: Leukemia
Interventions: gemtuzumab ozogamicin, observation, Cytosine arabinoside, Daunomycin
First posted: 2004-06-16
Last updated: 2015-09-30
Results first posted: 2012-08-27

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	2-year Disease-free Survival (DFS)	After completing any treatment, every 6 months for 2 years, than annually for years 3-5	Measured from data of randomization to post-consolidation therapy until relapse from complete response or death from any cause, with observations censored at the date of last contact for patients last known to be alive without report of relapse.
Primary	Complete Remission	After induction therapy was completed (1 or 2 months)
Secondary	Toxicity	For induction, daily for the first 10 days, then twice weekly until consolidation treatment. Weekly during consolidation treatment. Weekly if randomized to post-consolidation G.O.	Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	2-year Disease-free Survival (DFS)	After completing any treatment, every 6 months for 2 years, than annually for years 3-5	Eligible patients who completed induction and consolidation therapy	Percentage of population	NUMBER
PRIMARY	Complete Remission	After induction therapy was completed (1 or 2 months)	Eligible patients who did not withdraw consent	participants	NUMBER
SECONDARY	Toxicity	For induction, daily for the first 10 days, then twice weekly until consolidation treatment. Weekly during consolidation treatment. Weekly if randomized to post-consolidation G.O.	Eligible patients who started therapy	Participants with a given type of AE	NUMBER

Source ClinicalTrials.gov

Results by group836

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

Outcome	Group	Category	Value	Spread	Units
2-year Disease-free Survival (DFS)	Post-consolidation GO		39	95% Confidence Interval 27 to 51	Percentage of population
2-year Disease-free Survival (DFS)	Post-consolidation Observation		50	95% Confidence Interval 38 to 62	Percentage of population
Complete Remission	Ara-C+Daunomycin		203		participants
Complete Remission	Ara-C+Daunomycin+Mylotarg		207		participants
Toxicity	Ara-C+Daunomycin+Mylotarg	ALT, SGPT (serum glutamic pyruvic transaminase)	29		Participants with a given type of AE
Toxicity	Ara-C+Daunomycin	ALT, SGPT (serum glutamic pyruvic transaminase)	11		Participants with a given type of AE
Toxicity	Ara-C Consolidation	ALT, SGPT (serum glutamic pyruvic transaminase)	22		Participants with a given type of AE
Toxicity	Post-consolidation G.O.	ALT, SGPT (serum glutamic pyruvic transaminase)	2		Participants with a given type of AE
Toxicity	Ara-C+Daunomycin+Mylotarg	AST, SGOT (serum glut. oxaloacetic transaminase)	32		Participants with a given type of AE
Toxicity	Ara-C+Daunomycin	AST, SGOT (serum glut. oxaloacetic transaminase)	11		Participants with a given type of AE

1 to 10 of 836Source ClinicalTrials.gov

See all 836 results by group

Participant flow10

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ara-C+Daunomycin+Mylotarg	317
Overall Study	STARTED	ARA-C+Daunomycin	320
Overall Study	Eligible	Ara-C+Daunomycin+Mylotarg	298
Overall Study	Eligible	ARA-C+Daunomycin	301
Overall Study	Eligible and Did Not Withdraw Consent	Ara-C+Daunomycin+Mylotarg	296
Overall Study	Eligible and Did Not Withdraw Consent	ARA-C+Daunomycin	300
Overall Study	COMPLETED	Ara-C+Daunomycin+Mylotarg	264
Overall Study	COMPLETED	ARA-C+Daunomycin	270
Overall Study	NOT COMPLETED	Ara-C+Daunomycin+Mylotarg	53
Overall Study	NOT COMPLETED	ARA-C+Daunomycin	50

Source ClinicalTrials.gov

Adverse events476

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	Febrile neutropenia	Blood and lymphatic system disorders	Induction 7 + 3 + G.O.	172	293	172
other	Febrile neutropenia	Blood and lymphatic system disorders	Induction 7 + 3	194	293	194
other	Febrile neutropenia	Blood and lymphatic system disorders	Ara-C Consolidation	178	375	178
other	Febrile neutropenia	Blood and lymphatic system disorders	Post-consolidation G.O.	14	78	14
other	Hemoglobin	Blood and lymphatic system disorders	Induction 7 + 3 + G.O.	116	293	116
other	Hemoglobin	Blood and lymphatic system disorders	Induction 7 + 3	109	293	109
other	Hemoglobin	Blood and lymphatic system disorders	Ara-C Consolidation	201	375	201
other	Hemoglobin	Blood and lymphatic system disorders	Post-consolidation G.O.	27	78	27
other	Vision-blurred vision	Eye disorders	Induction 7 + 3 + G.O.	0	293	0
other	Vision-blurred vision	Eye disorders	Induction 7 + 3	0	293	0

1 to 10 of 476Source ClinicalTrials.gov

See all 476 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Induction 7 + 3 + G.O.
Total, all-cause mortality	Induction 7 + 3
Total, all-cause mortality	Ara-C Consolidation
Total, all-cause mortality	Post-consolidation G.O.
Total, other adverse events	Induction 7 + 3 + G.O.	277	293
Total, other adverse events	Induction 7 + 3	279	293
Total, other adverse events	Ara-C Consolidation	356	375
Total, other adverse events	Post-consolidation G.O.	77	78
Total, serious adverse events	Induction 7 + 3 + G.O.	47	293
Total, serious adverse events	Induction 7 + 3	9	293

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23591789	DERIVED	PubMed
24383844	DERIVED	PubMed
25527568	DERIVED	PubMed
37267439	DERIVED	PubMed
37534515	DERIVED	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
U10CA032102	Southwest Oncology Group Treatment Grant	BLANKE, CHARLES D.	OREGON HEALTH & SCIENCE UNIVERSITY	NATIONAL CANCER INSTITUTE	1985 to 2013

Source NIH RePORTER

Trial comparisons1

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

Comparison
Ara-C+Daunomycin vs Ara-C+Daunomycin+Mylotarg: Complete Remission

Source 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.

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