Status:
RECRUITING
Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 d...
Detailed Description
PRIMARY OBJECTIVES: I. Evaluate the safety of a regimen incorporating fludarabine phosphate (fludarabine), high-dose cytarabine, filgrastim-sndz, gemtuzumab ozogamicin and idarubicin hydrochloride (i...
Eligibility Criteria
Inclusion
- 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
- Pregnant and lactating females will be excluded
Key Trial Info
Start Date :
April 4 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 11 2028
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00801489
Start Date
April 4 2007
End Date
October 11 2028
Last Update
October 9 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030