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NCT00801489 · ClinicalTrials.gov registry record · Phase 2
Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
A Phase 2 study of High Risk Myelodysplastic Syndrome and Untreated Adult Acute Myeloid Leukemia, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 270
- Enrollment target
- 1
- Study location
NCT00801489 is a Phase 2 study of High Risk Myelodysplastic Syndrome and Untreated Adult Acute Myeloid Leukemia that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 270 participants, above the 77-participant average among 12 other High Risk Myelodysplastic Syndrome trials with a reported enrollment target (251% higher). The trial reports 1 study location across 1 state.
The verdict
NCT00801489, a Phase 2 study of High Risk Myelodysplastic Syndrome and Untreated Adult Acute Myeloid Leukemia, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 270 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies the side effects and how well fludarabine phosphate, cytarabine, filgrastim-sndz, gemtuzumab ozogamicin, and idarubicin hydrochloride work in treating patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. Drugs used in chemotherapy, such as fludarabine phosphate, cytarabine, and idarubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to a antitumor drug, called calicheamicin. Gemtuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD33 receptors, and delivers calicheamicin to kill them. Colony-stimulating factors, such as filgrastim-sndz, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving fludarabine phosphate, cytarabine, filgrastim-sndz, gemtuzumab ozogamicin, and idarubicin hydrochloride may kill more cancer cells.
Conditions Studied
Interventions
- DRUG Decitabine
- DRUG Gemtuzumab Ozogamicin
- DRUG Cytarabine
- DRUG Fludarabine Phosphate
- BIOLOGICAL Filgrastim-sndz
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2007-04-04 |
| Est. Completion | 2028-10-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00801489
The ClinicalTrials.gov registry entry for NCT00801489 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 270 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 77-participant average among 12 other High Risk Myelodysplastic Syndrome trials with a reported enrollment target (251% higher). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with High Risk Myelodysplastic Syndrome appearing as the primary indexed condition, and to 5 interventions - of which Decitabine is the first listed.
NCT00801489 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00801489 about?
NCT00801489 is a clinical study titled "Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome". This phase II trial studies the side effects and how well fludarabine phosphate, cytarabine, filgrastim-sndz, gemtuzumab ozogamicin, and idarubicin hydrochloride work in treating patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. Drugs used in chemotherapy, s...
What is the current status of trial NCT00801489?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 270 participants. The study started on 2007-04-04. Estimated completion is 2028-10-11.
What conditions does trial NCT00801489 study?
This clinical trial studies the following conditions: High Risk Myelodysplastic Syndrome, Untreated Adult Acute Myeloid Leukemia, de Novo Myelodysplastic Syndrome, Myelodysplastic Syndrome With Excess Blasts, Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1.
What interventions are being tested in trial NCT00801489?
The interventions under investigation include: Decitabine (DRUG), Gemtuzumab Ozogamicin (DRUG), Cytarabine (DRUG), Fludarabine Phosphate (DRUG), Filgrastim-sndz (BIOLOGICAL).
Who is sponsoring clinical trial NCT00801489?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00801489 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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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.