Obinutuzumab and Ibrutinib as Front Line Therapy in Treating Patients With Indolent Non-Hodgkin's Lymphomas
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Ann Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
- Ann Abor Stage III B-Cell Non-Hodgkin Lymphoma
- Ann Arbor Stage II Follicular Lymphoma
- Ann Arbor Stage II Nodal Marginal Zone Lymphoma
- Stage IV Splenic Marginal Zone Lymphoma
- Non Hodgkin's Lymphoma
- Stage II Splenic Marginal Zone Lymphoma
- Ann Arbor Stage III Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
- Grade 3a Follicular Lymphoma
- Ann Arbor Stage III Follicular Lymphoma
- Ann Arbor Stage III Nodal Marginal Zone Lymphoma
- Grade 2 Follicular Lymphoma
- Ann Arbor Stage IV B-Cell Non-Hodgkin Lymphoma
- Ann Arbor Stage IV Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
- Stage III Splenic Marginal Zone Lymphoma
- Ann Arbor Stage IV Follicular Lymphoma
- Indolent Non Hodgkin Lymphoma
- Grade 1 Follicular Lymphoma
- Ann Arbor Stage IV Nodal Marginal Zone Lymphoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To assess the efficacy of the combination of ibrutinib and obinutuzumab in chemotherapy naive patients with indolent lymphomas. SECONDARY OBJECTIVES: I. To assess progression free survival rates and overall survival rates in indolent lymphomas. II. To assess safety and tolerab...
PRIMARY OBJECTIVES: I. To assess the efficacy of the combination of ibrutinib and obinutuzumab in chemotherapy naive patients with indolent lymphomas. SECONDARY OBJECTIVES: I. To assess progression free survival rates and overall survival rates in indolent lymphomas. II. To assess safety and tolerability of the combination. III. To evaluate response using positron emission tomography (PET) and correlate PET negativity with durability of response.
Tracking Information
- NCT #
- NCT03198026
- Collaborators
- Genentech, Inc.
- Pharmacyclics LLC.
- Investigators
- Principal Investigator: Ubaldo Martinez-Outschoorn, MD Sidney Kimmel Cancer Center at Thomas Jefferson University