Clinical Trials for Leukemia

If you’re diagnosed with leukemia, you can’t wait six to 12 months for the FDA to approve a drug. You need it now. Our goal is to provide our patients with cutting-edge, groundbreaking therapies even before those treatments are widely available. For example, in 2017-2019, nine new therapies were approved by the FDA for the treatment of acute myeloid leukemia (AML). Patients enrolled in clinical trials at Roswell Park had access to seven of those drugs before they were FDA-approved.

Half or more of all Roswell Park patients are eligible to enroll in a clinical trial of a promising new treatment. All of today’s standard treatments had to be tested in clinical trials before they received FDA approval.

Through clinical trials, leukemia patients at Roswell Park were among the first to benefit from imatinib mesylate (Gleevec®), FDA-approved in 2001 for the treatment of chronic myeloid leukemia (CML).

Between 2017-2019, the FDA approved nine new drugs for different categories of patients with acute myeloid leukemia. Roswell Park patients who enrolled in clinical trials had access to seven of these drugs prior to FDA approval:

  • Ivosidenib (Tibsovo®) — FDA-approved in July 2018 and May 2019.
  • Venetoclax (Venclexta®) — FDA-approved in November 2018.
  • Glasdegib (Daurismo) — FDA-approved in November 2018.
  • Gilteritinib (Xospata®)— FDA-approved in November 2018.
  • Gemtuzumab ozogamicin (Mylotarg) — FDA-approved in September 2017.
  • Enasidenib (Idhifa®) — FDA-approved in August 2017.
  • Midostaurin (Rydapt®) —FDA-approved in April 2017.

In addition, patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) who enrolled in a clinical trial received treatment with tagraxofusp-erzs (Elzonris) before it was approved by the FDA.

At any given time, we offer an average of 15-25 clinical trials for all stages and diagnoses of acute and chronic leukemia as well as myeloid malignancies. View a list of leukemia clinical trials that are currently open.