Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 2 study of High Risk Myelodysplastic Syndrome and Untreated Adult Acute Myeloid Leukemia, sponsored by M.D. Anderson Cancer Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What NCT00801489 shows while recruiting
NCT00801489 is an interventional study that assigns participants to a tested intervention. The registered 270 participants enrollment target is mid-sized for trials with a published cap, above the 77-participant average among 12 other High Risk Myelodysplastic Syndrome trials with a reported enrollment target (251% higher).
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 a single indexed study location in 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, Myelodysplastic Syndrome With Excess Blasts, de Novo Myelodysplastic Syndrome, 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.
Learn More About Clinical Trials
Similar trials for High Risk Myelodysplastic Syndrome
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 NCT00801489's enrollment target sits among peer trials
270 1st of 12 higher than 12 of 12 other High Risk Myelodysplastic Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other High Risk Myelodysplastic Syndrome 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
-
Dexrazoxane Hydrochloride in Preventing Heart-Related Side Effects of Chemotherapy in Participants With Blood Cancers
RECRUITING · Phase 2
-
Liposome-encapsulated Daunorubicin-Cytarabine and Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome
ACTIVE NOT RECRUITING · Phase 2
-
Total Marrow and Lymphoid Irradiation as Conditioning Regimen Before Hematopoietic Cell Transplantation in Patients With Myelodysplastic Syndrome or Acute Leukemia
ACTIVE NOT RECRUITING · Phase 2
-
Busulfan, Fludarabine Phosphate, and Post-Transplant Cyclophosphamide in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant
ACTIVE NOT RECRUITING · Phase 2
-
Venetoclax With Combination Chemotherapy in Treating Patients With Newly Diagnosed or Relapsed or Refractory Acute Myeloid Leukemia
RECRUITING · Phase 1
-
Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome
RECRUITING · Phase 1
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
- NCT04372485 · 270 participants · NA
Using Mobile Health (mHealth) to Improve STI Treatment Adherence Among Adolescents
- NCT04528446 · 270 participants
The Impact of Glomerular Disorders on Bone Quality and Strength
- NCT05215327 · 270 participants · Phase 2
High vs. Standard Dose Influenza Vaccine in Lung Allograft Recipients
- NCT05362292 · 270 participants · Phase 4
TReating Incontinence for Underlying Mental and Physical Health
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