Clinical Trial Detail

Clinical Trials

Clinical Trial Detail

Higher or Lower Dose Cladribine, Cytarabine, and Mitoxantrone in Treating Medically Less Fit Patients With Newly Diagnosed Acute Myeloid Leukemia or Myeloid Neoplasm

Complete title: Impact of Treatment Intensity on Survival, Quality of Life, and Resource Utilization in Medically Less Fit Adults with Acute Myeloid Leukemia and Analogous Myeloid Neoplasms: A Randomized Pilot Study

Research Study Number 9759
Principal Investigator Anna Halpern
Phase II

Research Study Description

This randomized pilot trial studies how well higher or lower dose cladribine, cytarabine, and mitoxantrone work in treating medically less fit patients with newly diagnosed acute myeloid leukemia or myeloid neoplasm. Drugs used in chemotherapy, such as cladribine, cytarabine, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cladribine, cytarabine, and mitoxantrone at higher or lower dose may work better in treating patients with newly diagnosed acute myeloid leukemia.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older (Adult, Senior)

Genders Eligible for Study: All

- Diagnosis of untreated "high-grade" myeloid neoplasm (>= 10% myeloid blasts by morphology in bone marrow and/or peripheral blood) or AML other than acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) or variants according to the 2016 World Health Organization (WHO) classification; patients with acute leukemias of ambiguous lineage are eligible; outside diagnostic material is acceptable as long as peripheral blood and/or bone marrow slides are reviewed at the study institution and cytogenetic/molecular information is available

- Treatment-related mortality (TRM) score >= 13.1 as calculated with simplified model

- The use of hydroxyurea before enrollment is permitted; hydroxyurea should be discontinued prior to start of study treatment; patients with symptoms/signs of hyperleukocytosis or white blood cell count (WBC) >100,000/uL can be treated with leukapheresis or may receive up to 1 dose of cytarabine (up to 500 mg/m^2) anytime prior to enrollment

- Patients may have received treatment (e.g. azacitidine/decitabine, lenalidomide, growth factors) for antecedent low-grade myeloid neoplasm

- Left ventricular ejection fraction (LVEF) >= 45%, assessed within 3 months prior to registration, e.g. by multigated acquisition (MUGA) scan or echocardiography, or other appropriate diagnostic modality

- Women of childbearing potential and men must agree to use adequate contraception beginning at the signing of the consent until at least 4 weeks after the last dose of study drug

- Ability to understand and the willingness to sign a written informed consent document

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- Myeloid blast crisis of chronic myeloid leukemia (CML), unless patient is not considered candidate for tyrosine kinase inhibitor treatment

- Concomitant illness associated with a likely survival of < 1 year

- Active systemic fungal, bacterial, viral, or other infection, unless disease is under treatment with anti-microbials and/or controlled or stable; patients with fever thought to be likely secondary to leukemia are eligible; known hypersensitivity to any study drug

- Known hypersensitivity to any study drug used in this trial

- Pregnancy or lactation

- Concurrent treatment with any other anti-leukemia agent

Other exclusion criteria may apply.

Research Study Number 9759
Contact Seattle Cancer Care Alliance Intake Office
Telephone 800-804-8824 / 206-606-1024

Keywords: Leukemia, Acute Myeloid (AML); Hematologic Malignancies; Leukemia; Leukemia, Myeloid

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Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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