A Phase IB Study of GDC-0199 (ABT-199 or Venetoclax) with R-CHOP or G-CHOP in Patients with B-Cell Non-Hodgkin Lymphoma

Full Title

A Phase Ib/II, Open-Label Study Evaluating the Safety and Pharmacokinetics of GDC-0199 (ABT-199) in Combination with Rituximab (R) or Obinutuzumab (G) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Patients with B-cell Non-Hodgkin’s Lymphoma (NHL) and DLBCL

Purpose

R-CHOP (a combination of the drugs rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) is a standard therapy for non-Hodgkin lymphoma. G-CHOP is another combination therapy in which the investigational drug obinutuzumab is given in place of rituximab. Another study is comparing R-CHOP with G-CHOP, which so far shows that G-CHOP is at least as effective as R-CHOP.

Doctors are interested in learning if adding the drug GDC-0199 (also called ABT-199 or venetoclax) to R-CHOP and G-CHOP increases the effectiveness of therapy. In this study, researchers want to determine the highest dose of GDC-0199 that can be given safely with R-CHOP and G-CHOP in patients with B-cell non-Hodgkin lymphoma. They will also look at how patients’ immune systems respond to GDC-0199.

Patients will receive GDC-0199 with either R-CHOP or G-CHOP, but not both. GDC-0199 works by blocking Bcl-2, a protein overproduced by many non-Hodgkin lymphoma cells that makes these cancer cells live longer. It is approved for the treatment of some patients with chronic lymphocytic leukemia. It is a tablet that is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have non-Hodgkin lymphoma. Patients with mantle cell lymphoma or small lymphocytic lymphoma may not participate.
  • Patients may have had up to one prior regimen of therapy, but may not have received R-CHOP.
  • At least 4 weeks must pass between the completion of previous treatment and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Andrew Zelenetz at 212-639-2656.

Protocol

14-130

Phase

I/II

Investigator

Zelenetz, Andrew, MD, PhD

Co-Investigators