Who is eligible for clinical trial NCT00801489?

Participants must meet the protocol's inclusion criteria for Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT00801489 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-03-24

Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (NCT00801489)

A Phase 2 Study of Fludarabine, Cytarabine, Filgrastim-sndz,Gemtuzumab Ozogamicin and Idarubicin in Newly Diagnosed Core Binding Factor Associated Acute Myelogenous Leukemia

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: M.D. Anderson Cancer Center

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (2 items).

Location: M D Anderson Cancer Center — Houston, Texas

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Patients must have untreated AML, or high-risk myelodysplastic syndromes (MDS) (refractory anemia with excess blasts, \[RAEB\], or RAEB "in transformation" \[RAEB-t\]) characterized by t(8;21), inv(16), or t(16;16); the presence of additional abnormalities is irrelevant
Patients must provide written consent
Participants will not be excluded based on performance status; for patients with Eastern Cooperative Oncology Group (ECOG) performance status \>= to 3 the dosing schedule will be discussed with study chairman
Patients with organ dysfunction will not be excluded from the study; for patients with evidence of organ dysfunction (creatinine \>= 1.5, cardiac ejection fraction =\< 50%, total bilirubin \>=2 and aspartate aminotransferase \[AST\]/alanine aminotransferase \[ALT\] \>= 3 times upper limit of normal \[ULN\]), dose adjustments/omissions will be made
Up to one cycle of prior induction therapy will be permitted to include patients in whom presence of "good-risk" cytogenetics was initially missed; if the patient is in remission from induction therapy, he/she will receive post-remission therapy; if the patient is not in remission then he/she will receive induction therapy
Patients of child bearing potential should practice effective methods of contraception

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Pregnant and lactating females will be excluded

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

M D Anderson Cancer Center — Houston, Texas

📞 Contact the Study Coordinator

Phone: (713) 563-1586

Email: gborthak@mdanderson.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11 clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗