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Protocol No. PRE0403

Principal Investigator Fletcher, Christopher

Phase II

Age Group Adult

Scope National

Sponsor Type Industry

Title Phase II Study of Venetoclax (ABT-199/GDC-0199) in Combination with Obinutuzumab and Bendamustine in Patient with High Tumor Burden Follicular Lymphoma

Objective The purpose of this study is to determine if venetoclax in combination with obinutuzumab and bendamustine chemotherapy is effective in treating people who have follicular lymphoma and to examine the side effects associated with this combination

Treatment
Induction:. Venetoclax, obinutuzumab and bendamustine will be administered for six (6) cycles with each cycle lasting 28 day

Maintenance: Obinutuzumab will be administered alone or in combination with venetoclax for up to two years

Description
Phase II study: Venetoclax with Obinutuzumab and Bendamustine, for high tumor burden follicular lymphoma

Both venetoclax and obinutuzumab are approved by the FDA (Food and Drug Administration) for treating patients when used individually, however they have not been used in combination and the FDA considers their use in this study to be investigational (not FDA approved)

Bendmustine has been approved by the FDA and is not considered investigational in this study

Key Eligibility
  • Patients must have a histologically confirmed (biopsy-proven) diagnosis of follicular B-cell non-Hodgkin lymphoma, with no evidence of transformation to large cell histology.
  • Patient must meet criteria for High Tumor Burden (higher risk)
  • Patient must have Stage II, III or IV. disease
  • Patient must have at least one objective measurable disease parameter. Measurable disease in the liver is required if the liver is the only site of lymphoma
  • ECOG 0-2
  • Women must not be pregnant or breastfeeding
  • Females of childbearing potential who are sexually active with a non-sterilized male partner and sexually active men must agree to use 2 methods of adequate contraception
  • Patient must have had no prior chemotherapy, radiotherapy or immunotherapy for lymphoma
  • Patients must be tested for hepatitis B virus, hepatitis B surface antigen and hepatitis C antibody
  • HIV patients are not excluded but must meet certain criteria
  • Can not be on warfarin but other blood thinners are permitted

  • Applicable Disease Sites Lymphoma

    Status Open

    Participating Institutions UW Hospital and Clinics