Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00658814 · ClinicalTrials.gov registry record · Phase 2
Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
A Phase 2 study of Acute Myeloid Leukemia and Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 133
- Enrollment target
- 20
- Study locations
NCT00658814: Active Phase 2 study of Acute Myeloid Leukemia and Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, sponsored by National Cancer Institute (NCI).
NCT00658814 is a Phase 2 study of Acute Myeloid Leukemia and Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 133 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (16% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00658814, a Phase 2 study of Acute Myeloid Leukemia and Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 133 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial is studying the side effects of giving azacitidine together with gemtuzumab ozogamicin to see how well it works in treating older patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Azacitidine may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving azacitidine together with gemtuzumab ozogamicin may kill more cancer cells.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Azacitidine
- DRUG Gemtuzumab Ozogamicin
Study Locations (20)
Illinois
- OSF Saint Anthony's Health Center - Alton
- Decatur Memorial Hospital - Decatur
- Heartland Cancer Research NCORP - Decatur
- Advocate Sherman Hospital - Elgin
- Loyola University Medical Center - Maywood
- SSM Health Good Samaritan - Mount Vernon
- Springfield Memorial Hospital - Springfield
Kansas
- Hospital District Sixth of Harper County - Anthony
- Cancer Center of Kansas - Chanute - Chanute
- Cancer Center of Kansas - Dodge City - Dodge City
- Cancer Center of Kansas - El Dorado - El Dorado
- Cancer Center of Kansas - Fort Scott - Fort Scott
- Cancer Center of Kansas-Independence - Independence
California
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Stanford Cancer Institute Palo Alto - Palo Alto
- University of California Davis Comprehensive Cancer Center - Sacramento
Indiana
- Franciscan Saint Francis Health-Beech Grove - Beech Grove
- Reid Health - Richmond
Connecticut
- Smilow Cancer Hospital Care Center at Saint Francis - Hartford
Idaho
- Saint Alphonsus Cancer Care Center-Boise - Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2008-12-01 |
| Est. Completion | 2026-03-19 |
| Phase | Phase 2 |
What the registry record for NCT00658814 still lists
NCT00658814 is an interventional study that assigns participants to a tested intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (16% higher).
The record links to 10 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Azacitidine is the first listed.
NCT00658814 names 20 study sites across 6 states, led by Illinois, Kansas, California.
Frequently Asked Questions
What is clinical trial NCT00658814 about?
NCT00658814 is a clinical study titled "Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia". This phase II trial is studying the side effects of giving azacitidine together with gemtuzumab ozogamicin to see how well it works in treating older patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth ...
What is the current status of trial NCT00658814?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 133 participants. The study started on 2008-12-01. Estimated completion is 2026-03-19.
What conditions does trial NCT00658814 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11, Adult Acute Monoblastic Leukemia, Adult Acute Monocytic Leukemia.
What interventions are being tested in trial NCT00658814?
The interventions under investigation include: Azacitidine (DRUG), Gemtuzumab Ozogamicin (DRUG).
Who is sponsoring clinical trial NCT00658814?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00658814 being conducted?
This trial has 20 study locations across California, Connecticut, Idaho, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Myeloid Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00658814's enrollment target sits among peer trials
133 61st of 306 higher than 246 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure
RECRUITING · Phase 2
-
Venetoclax + Azacitidine vs. Induction Chemotherapy in AML
RECRUITING · Phase 2
-
A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)
RECRUITING · Phase 2
-
Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission
RECRUITING · Phase 2
-
A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy
RECRUITING · Phase 2
-
Venetoclax, Cladribine, Low Dose Cytarabine, and Azacitidine in Treating Patients With Previously Untreated Acute Myeloid Leukemia
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04276870 · 133 participants · Phase 2
Orphan Indications for CD19 Redirected Autologous T Cells
- NCT04671771 · 133 participants · NA
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
- NCT05610085 · 133 participants · Phase 2
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
- NCT06206486 · 133 participants
The Gut Microbiome and Serum Metabolites As a Biological Mechanism Underlying Pain in Kidney Transplantation
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI