Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
NCT00658814 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 133 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00658814 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Illinois, Kansas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00658814?
The interventions under investigation include: Azacitidine (DRUG), Gemtuzumab Ozogamicin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00658814?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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