RecruitingPhase 2NCT00801489

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


Sponsor

M.D. Anderson Cancer Center

Enrollment

270 participants

Start Date

Apr 4, 2007

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination chemotherapy regimen for people with a specific type of acute leukemia (AML) or high-risk pre-leukemia (MDS) that has particular chromosome changes, to see if treatment outcomes can be improved. **You may be eligible if...** - You have untreated acute myeloid leukemia (AML) or high-risk pre-leukemia (MDS) with specific chromosome changes: t(8;21), inv(16), or t(16;16) - You are willing to provide written consent - You may have received up to one prior round of induction chemotherapy - You are of childbearing potential and willing to use effective contraception **You may NOT be eligible if...** - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCytarabine

Given IV

DRUGDecitabine

Given IV

BIOLOGICALFilgrastim-sndz

Given SC

DRUGFludarabine Phosphate

Given IV

DRUGGemtuzumab Ozogamicin

Given IV

DRUGIdarubicin

Given IV

OTHERLaboratory Biomarker Analysis

Correlative studies


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT00801489


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