Trial · NCT00658814

Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

NCT00658814, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2014-01-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia. Trials, record NCT00658814. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00658814

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Trial

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

Title: Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
NCT number: NCT00658814
Status: Active not recruiting
Phases: Phase 2
Enrollment: 133 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Acute Myeloid Leukemia, Adult Acute Megakaryoblastic Leukemia, Adult Acute Monoblastic Leukemia, Adult Acute Monocytic Leukemia, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With Maturation, Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21)(q22;q22.1); RUNX1-RUNX1T1, Adult Acute Myeloid Leukemia With t(9;11)(p21.3;q23.3); MLLT3-KMT2A, Adult Acute Myeloid Leukemia Without Maturation, Adult Acute Myelomonocytic Leukemia, Adult Erythroleukemia, Adult Pure Erythroid Leukemia, Secondary Acute Myeloid Leukemia
Interventions: Azacitidine, Gemtuzumab Ozogamicin
First posted: 2008-04-15
Last updated: 2026-10-22
Results first posted: 2014-01-06

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Complete Response	Up to 60 days	Morphologic complete remission (CR): ANC \>=1,000/mcL, platelet count \>=100,000/mcL, \<5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be \<1,000/mcL and/or platelet count \<100,000/mcL.
Primary	30-Day Survival	30 days	Patients surviving more than 30 days after study registration
Secondary	Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Up to 5 years	Only adverse events that are possibly, probably or definitely related to study drug are reported.
Secondary	Relapse-free Survival	Up to 5 years	Relapse-free survival (RFS) is defined for all patients who achieve CR or CRi. RFS is measured from the date CR or CRi is first achieved until relapse or death form any cause, with observation censored on the date of last contact for patients last known to be alive without report of relapse. Relapse from CR/CRi is defined as reappearance of leukemic blasts in the peripheral blood; or \> 5% blasts in the bone marrow not attributable to another cause; or appearance or reappearance of extramedullary disease.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Up to 5 years	Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.	Participants	NUMBER
PRIMARY	Complete Response	Up to 60 days		percentage of participants	NUMBER
PRIMARY	30-Day Survival	30 days		percentage of participants	NUMBER
SECONDARY	Relapse-free Survival	Up to 5 years		months	MEDIAN

Source ClinicalTrials.gov

Results by group237

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

Outcome	Group	Category	Value	Units
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Remission Induction Chemotherapy	ALT, SGPT (serum glutamic pyruvic transaminase)	5	Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Consolidation Therapy	ALT, SGPT (serum glutamic pyruvic transaminase)	0	Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Maintenance Therapy	ALT, SGPT (serum glutamic pyruvic transaminase)	0	Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Remission Induction Chemotherapy	AST, SGOT	4	Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Consolidation Therapy	AST, SGOT	0	Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Maintenance Therapy	AST, SGOT	0	Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Remission Induction Chemotherapy	Adult respiratory distress syndrome (ARDS)	1	Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Consolidation Therapy	Adult respiratory distress syndrome (ARDS)	0	Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Maintenance Therapy	Adult respiratory distress syndrome (ARDS)	0	Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Remission Induction Chemotherapy	Albumin, serum-low (hypoalbuminemia)	5	Participants

1 to 10 of 237Source ClinicalTrials.gov

See all 237 results by group

Participant flow26

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

Period	Milestone	Group	Participants
Remission Induction Chemotherapy	STARTED	Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin	83
Remission Induction Chemotherapy	STARTED	Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin	59
Remission Induction Chemotherapy	Eligible	Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin	82
Remission Induction Chemotherapy	Eligible	Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin	57
Remission Induction Chemotherapy	Eligible and Began Protocol Therapy	Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin	79
Remission Induction Chemotherapy	Eligible and Began Protocol Therapy	Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin	54
Remission Induction Chemotherapy	COMPLETED	Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin	75
Remission Induction Chemotherapy	COMPLETED	Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin	41
Remission Induction Chemotherapy	NOT COMPLETED	Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin	8
Remission Induction Chemotherapy	NOT COMPLETED	Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin	18

1 to 10 of 26Source ClinicalTrials.gov

See all 26 participant flow

Adverse events444

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	Febrile neutropenia	Blood and lymphatic system disorders	Remission Induction Chemotherapy	49	133
other	Febrile neutropenia	Blood and lymphatic system disorders	Consolidation Therapy	1	32
other	Febrile neutropenia	Blood and lymphatic system disorders	Maintenance Therapy	0	27
other	Hemoglobin	Blood and lymphatic system disorders	Remission Induction Chemotherapy	98	133
other	Hemoglobin	Blood and lymphatic system disorders	Consolidation Therapy	20	32
other	Hemoglobin	Blood and lymphatic system disorders	Maintenance Therapy	15	27
other	Watery eye (epiphora, tearing)	Eye disorders	Remission Induction Chemotherapy	0	133
other	Watery eye (epiphora, tearing)	Eye disorders	Consolidation Therapy	3	32
other	Watery eye (epiphora, tearing)	Eye disorders	Maintenance Therapy	0	27
other	Constipation	Gastrointestinal disorders	Remission Induction Chemotherapy	47	133

1 to 10 of 444Source ClinicalTrials.gov

See all 444 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Remission Induction Chemotherapy
Total, all-cause mortality	Consolidation Therapy
Total, all-cause mortality	Maintenance Therapy
Total, other adverse events	Remission Induction Chemotherapy	130	133
Total, other adverse events	Consolidation Therapy	32	32
Total, other adverse events	Maintenance Therapy	26	27
Total, serious adverse events	Remission Induction Chemotherapy	55	133
Total, serious adverse events	Consolidation Therapy	1	32
Total, serious adverse events	Maintenance Therapy	3	27

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24092933	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/NCT00658814

GET https://conductscience.org/api/trials/v1/NCT00658814/results?page=2

API reference For AI assistants