Combination chemotherapy for newly diagnosed acute myeloid leukemia and high-risk myelodysplastic syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• M D Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Jayastu Senapati — M.D. Anderson Cancer Center
• Study coordinator: Jayastu Senapati
• Email: JSenapati@mdanderson.org
• Phone: 713-745-9200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.