IIT: A Phase II study of Obinutuzumab (GA-101) in Combination with Ibrutinib (I) for the Treatment of Relapsed Mantle Cell Lymphoma (ML29535)
The purpose of this study is to test the safety of obinutuzumab, the study drug, in combination with ibrutinib and find out what effects, if any, this drug combination has on people with relapsed/refractory mantle cell lymphoma cancer.
Mantle cell lymphoma, relapsed/refractory, hematologic malignancies, oncology
Participants must have a diagnosis of Relapsed or Refractory Mantle Cell Lymphoma and be 18 years or older.
Exclusion criteria include:
- active graft versus host disease (GVHD)
- known HIV infection or active HCV infection
- pregnant or breastfeeding women
- participants actively receiving another investigational product
- history of stroke within previous 6 months
- required use of anticoagulation with warfarin or equivalent vitamin K antagonists
18 - 99
Healthy Volunteers Needed
Duration of Participation
For participants who complete all study visits participation will last approximately five years. The study drug will be administered on days 1, 8, and 15 for Cycle 1 and on day 1 for Cycles 2 through 6. Each cycle is 28 days long. At the end of these six cycles, participants will continue to receive study drug maintenance every two months for up to two years (a total of 12 study drug doses). After completion of these visits, participants will continue on standard of care treatment. Every six months, for up to five years, the investigator may query participant patient records for disease progression information and survival status.
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