A Study Being Conducted at Multiple Locations to Compare Safety and Efficacy of Three Different Regimens; (1) High-Dose Lenalidomide; (2) Lenalidomide + Azacitidine; or (3) Azacitidine in Subjects ≥ 65 Years With Newly-Diagnosed Acute Myeloid Leukemia

The study aim is to compare safety and efficacy of high-dose lenalidomide regimen, sequential azacitidine and lenalidomide and an azacitidine in persons ≥65 years with newly-diagnosed acute myeloid leukemia (AML).

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: Azacitidine
  • drug: Lenalidomide
  • other: Best Supportive Care (BSC)

Eligibility


Inclusion Criteria:

   - Newly diagnosed acute myeloid leukemia (AML), AML with antecedent hematologic disorder
   or therapy-related AML

   - Male or female subjects aged ≥ 65

   - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

   - White blood cell (WBC) count ≤ 10 x 10⁹/L at screening

Exclusion Criteria:

   - Previous treatment with azacitidine, decitabine, cytarabine or lenalidomide

   - Previous cytotoxic or biologic treatment of any kind for AML or prior use of targeted
   therapy agents.

   - Suspected or proven acute promyelocytic leukemia

   - Prior bone marrow or stem cell transplantation

   - Candidate for allogeneic bone marrow or stem cell transplantation

   - AML antecedent hematologic disorder such as chronic myelogenous leukemia or
   myeloproliferative neoplasms

   - Presence of malignant disease within the previous 12 months with exceptions

Ages Eligible for Study

65 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation,  mobile application development, and pharmaceutical trials.  

Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.