Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Calithera Biosciences, Inc
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of AML or ALL, relapsed or refractory after at least 1 prior treatment regimen. Newly-diagnosed patients ≥ 60 years old who have refused or are considered unfit for standard chemotherapy regimens or stem cell transplantation are also eligible.
Patients must have no available approved therapies that confer clinical benefit
All patients must have bone marrow involvement of their tumor, with documented blast percentage of \> 5%.
Peripheral blood blast count must be ≤ 30,000 cells/µL.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Adequate hepatic, renal, and cardiac function
You may not be if
Any other current malignancy
Patients with acute promyelocytic leukemia (APL)
Treatment with an unapproved, investigational agent within 21 days of the first dose of study drug
Allogeneic hematopoietic stem cell transplant or Donor Lymphocyte Infusion within 90 days prior to to the first dose of study drug
Active GVHD
Unable to receive medications by mouth
Major surgery within 28 days before Cycle 1 Day 1
Uncontrolled, active infection; patients who are known to have HIV infection/ seropositivity, Hepatitis A, B, or C, or CMV reactivation
Significant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days prior to Day 1
Refractory nausea and vomiting or other situation that may preclude adequate absorption
Conditions that could interfere with treatment and procedures
