Combination chemotherapy for newly diagnosed acute myeloid leukemia and 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

This study is testing a mix of chemotherapy drugs to see if they can help people with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome achieve remission and live longer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 270 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (other)
• Drugs / interventions: gemtuzumab, chemotherapy, fludarabine
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT00801489 on ClinicalTrials.gov

What this trial studies

This phase II trial evaluates the safety and effectiveness of a combination of chemotherapy drugs, including fludarabine phosphate, cytarabine, filgrastim-sndz, gemtuzumab ozogamicin, and idarubicin hydrochloride, in treating patients with newly diagnosed acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). The study aims to determine the complete remission rates and assess the long-term survival of patients who achieve remission. Participants will receive a specific regimen of these drugs, with adjustments made for those with organ dysfunction. The trial also explores the use of quantitative polymerase chain reaction (Q-PCR) to detect potential relapses.

Who should consider this trial

Good fit: Ideal candidates include patients with untreated acute myeloid leukemia or high-risk myelodysplastic syndromes characterized by specific genetic abnormalities.

Not a fit: Patients with advanced organ dysfunction or those who have received multiple prior treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve remission rates and overall survival for patients with aggressive forms of leukemia and myelodysplastic syndromes.

How similar studies have performed: Other studies have shown promising results with similar chemotherapy regimens in treating acute myeloid leukemia, suggesting potential for success in this approach.

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

Where this trial is running

Houston, Texas

• M D Anderson Cancer Center — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Gautam Borthakur — M.D. Anderson Cancer Center
• Study coordinator: Gautam Borthakur

Conditions: Acute Myeloid Leukemia With Inv, CBFB-MYH11, Acute Myeloid Leukemia With t(16, 16)(p13.1, q22), Acute Myeloid Leukemia With t(8, 21), (q22