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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00658814
The ClinicalTrials.gov registry entry for NCT00658814 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 133 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (16% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.
-
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
Explore more on PlainTrial
Acute Myeloid Leukemia
All registered trials for this condition
Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
All registered trials for this condition
California
All trials with a study site in California
Recruiting now
Find trials open to new participants near you
Rankings
Top sponsors, conditions, and phases
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.