Trial · NCT00551460

S0535, Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia

NCT00551460, Phase 2, Completed, SWOG Cancer Research Network; results first posted 2017-12-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. S0535, Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia. Trials, record NCT00551460. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00551460

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Trial

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

Title: S0535, Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia
NCT number: NCT00551460
Status: Completed
Phases: Phase 2
Enrollment: 78 participants, actual
Lead sponsor: SWOG Cancer Research Network
Conditions: Leukemia
Interventions: arsenic trioxide, gemtuzumab ozogamicin, mercaptopurine, methotrexate, tretinoin
First posted: 2007-10-31
Last updated: 2023-01-10
Results first posted: 2017-12-22

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Continuous Complete Remission at 3 Years	3 years	Binary variable: yes if the patient achieves complete remission and remains in continuous complete remission until at least 3 years after entering the study; otherwise no.
Primary	Mortality Rate at 6 Weeks	6 weeks
Secondary	Frequency of Toxicities	Up to 3 years	Adverse events that were possibly, probably or definitely related to study drug are reported.

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	Continuous Complete Remission at 3 Years	3 years	The Analysis Population includes eligible and analyzable patients. Ineligible patients and not analyzable patients from Participant Flow are excluded.	percentage of participants	NUMBER
PRIMARY	Mortality Rate at 6 Weeks	6 weeks	The Analysis Population includes eligible and analyzable patients. Ineligible patients and not analyzable patients from Participant Flow are excluded.	percentage of participants	NUMBER
SECONDARY	Frequency of Toxicities	Up to 3 years	The Analysis Population includes eligible and analyzable patients. Ineligible patients and not analyzable patients from Participant Flow are excluded.	Participants	NUMBER

Source ClinicalTrials.gov

Results by group222

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

Outcome	Group	Category	Value	Spread	Units
Continuous Complete Remission at 3 Years	ATRA + GO + Arsenic		74	95% Confidence Interval 62 to 84	percentage of participants
Mortality Rate at 6 Weeks	ATRA + GO + Arsenic		11	95% Confidence Interval 5 to 21	percentage of participants
Frequency of Toxicities	ATRA + GO + Arsenic	ALT, SGPT (serum glutamic pyruvic transaminase)	37		Participants
Frequency of Toxicities	ATRA + GO + Arsenic	AST, SGOT	46		Participants
Frequency of Toxicities	ATRA + GO + Arsenic	Acidosis (metabolic or respiratory)	4		Participants
Frequency of Toxicities	ATRA + GO + Arsenic	Acute vascular leak syndrome	1		Participants
Frequency of Toxicities	ATRA + GO + Arsenic	Adult respiratory distress syndrome (ARDS)	3		Participants
Frequency of Toxicities	ATRA + GO + Arsenic	Albumin, serum-low (hypoalbuminemia)	24		Participants
Frequency of Toxicities	ATRA + GO + Arsenic	Alkaline phosphatase	23		Participants
Frequency of Toxicities	ATRA + GO + Arsenic	Alkalosis (metabolic or respiratory)	4		Participants

1 to 10 of 222Source ClinicalTrials.gov

See all 222 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	ATRA + GO + Arsenic	78
Overall Study	COMPLETED	ATRA + GO + Arsenic	60
Overall Study	NOT COMPLETED	ATRA + GO + Arsenic	18

Source ClinicalTrials.gov

Adverse events124

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	Blood/Bone Marrow-Other	Blood and lymphatic system disorders	ATRA + GO + Arsenic	4	70
other	DIC (disseminated intravascular coagulation)	Blood and lymphatic system disorders	ATRA + GO + Arsenic	17	70
other	Febrile neutropenia	Blood and lymphatic system disorders	ATRA + GO + Arsenic	29	70
other	Hemoglobin	Blood and lymphatic system disorders	ATRA + GO + Arsenic	40	70
other	SVT and nodal arrhythmia - Sinus bradycardia	Cardiac disorders	ATRA + GO + Arsenic	5	70
other	SVT and nodal arrhythmia - Sinus tachycardia	Cardiac disorders	ATRA + GO + Arsenic	19	70
other	Ocular/Visual-Other	Eye disorders	ATRA + GO + Arsenic	5	70
other	Vision-blurred vision	Eye disorders	ATRA + GO + Arsenic	7	70
other	Vision-photophobia	Eye disorders	ATRA + GO + Arsenic	4	70
other	Constipation	Gastrointestinal disorders	ATRA + GO + Arsenic	26	70

1 to 10 of 124Source ClinicalTrials.gov

See all 124 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ATRA + GO + Arsenic	10	70
Total, other adverse events	ATRA + GO + Arsenic	68	70
Total, serious adverse events	ATRA + GO + Arsenic	11	70

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32330241	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
U10CA032102	Southwest Oncology Group Treatment Grant	BLANKE, CHARLES D.	OREGON HEALTH & SCIENCE UNIVERSITY	NATIONAL CANCER INSTITUTE	1985 to 2013

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/NCT00551460

GET https://conductscience.org/api/trials/v1/NCT00551460/results?page=2

API reference For AI assistants