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

Launched by M.D. ANDERSON CANCER CENTER · Dec 2, 2008

Keywords

ClinConnect Summary

This clinical trial is studying a combination of medications to see how well they treat newly diagnosed acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS). The treatment includes several drugs that work together to kill cancer cells and help the immune system recover from any side effects caused by the chemotherapy. The goal is to determine how effective this treatment is and what side effects may occur.

To be eligible for the trial, participants must have untreated AML or high-risk MDS with specific genetic characteristics. This means that individuals with certain genetic changes in their cancer cells may qualify. Patients can be of any age starting from 65 and are not excluded based on their overall health status, although there may be some adjustments to the treatment if they have existing health issues. Participants will receive the combination of medications and will be closely monitored throughout the treatment to assess its effectiveness and manage any side effects. It's important for potential participants to discuss their eligibility and any concerns with their healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • Pregnant and lactating females will be excluded