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
Phase 2
Interventional Study
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
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 270 (estimated)
- Sponsor
- M.D. Anderson Cancer Center · Other
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About This Trial
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 st…
Trial Locations
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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
* Pati…
Contacts