A Phase Ib, Open-Label Study Evaluating the Safety and Pharmacokinetics of Atezolizumab (Anti-PD-L1 Antibody) Administered in Combination With Hu5F9-G4 to Patients With Relapsed and/or Refractory Acute Myeloid Leukemia
| Sponsor: |
F. Hoffmann - La Roche Ltd |
| Enrolling: |
Male and Female Patients |
| IRB Number: |
AAAS3836 |
| U.S. Govt. ID: |
NCT03922477 |
| Contact: |
Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu |
The main purposes of this study are to: 1) understand the safety of atezolizumab given in combination with Hu5F9-G4 and 2) understand the way the body processes atezolizumab and Hu5F9-G4 (pharmacokinetics). This study will also be testing if the combination therapy is effective at treating relapsed or refractory acute myeloid leukemia (R/R AML). Atezolizumab in combination with Hu5F9-G4 is an experimental treatment, which means health authorities have not approved these drugs in combination for the treatment of R/R AML. In total, approximately 21 subjects with R/R AML will take part in this study.
This study is closed
Investigator
Daniel Lee, MD
| Are you 18 years of age or older? |
Yes |
No |
| Do you have documented and confirmed Relapsed/Refractory Acute Myeloid Leukemia? |
Yes |
No |
| Are you willing and able to provide pretreatment bone marrow aspirate and biopsy? |
Yes |
No |
| Are you willing to provide bone marrow aspirates and biopsies during study treatment? |
Yes |
No |