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Study of Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride for AML and High-Risk MDS

This study is looking at how safe and effective a combination of drugs is for people with newly diagnosed acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). The drugs being tested are fludarabine phosphate, cytarabine, filgrastim-sndz, gemtuzumab ozogamicin, and idarubicin hydrochloride. Fludarabine phosphate, cytarabine, and idarubicin hydrochloride are chemotherapy drugs that work to stop cancer cells from growing. Gemtuzumab ozogamicin is a targeted therapy, meaning it specifically attacks cancer cells. The study aims to see how many patients achieve complete remission (where signs of cancer disappear) and to understand any side effects. You may be able to join if you are 18 or older and have untreated AML or high-risk MDS with specific genetic changes. The current status of this study is unclear.

Study design
This is a Phase II interventional study, meaning all participants receive the study treatment. It plans to enroll 270 participants.
What's involved
Participants will receive filgrastim-sndz daily, and fludarabine phosphate, cytarabine, and gemtuzumab ozogamicin on specific days during remission induction. If not in remission, induction therapy may be repeated.
Compensation
Not stated in the trial record.
Follow-up
The study measures complete remission and toxicity rates for up to 2 years. It also assesses how many patients remain in complete remission for two years.

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NCT00801489

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~270 participants
Updated 2026-03-30 on ClinicalTrials.gov
What's tested:CytarabineDecitabineFilgrastim-sndzFludarabine PhosphateGemtuzumab OzogamicinIdarubicin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete remission rate
Measured over Up to 2 years
+1 more outcome measured

Conditions

Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1
de Novo Myelodysplastic Syndrome
High Risk Myelodysplastic Syndrome
Inv(16)
Myelodysplastic Syndrome With Excess Blasts
t(16;16)
t(8;21)
Untreated Adult Acute Myeloid Leukemia

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Acute Myeloid LeukemiaMyelodysplastic SyndromeCD33 Geneinv(16)(p13.1;q22)t(8;21)(q22;q22)

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Gautam Borthakur · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Gautam Borthakur
[email protected]
713-563-1586
Email the study team

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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

What this trial measures

  • Complete remission rateUp to 2 years
  • Toxicity rateUp to 2 years