Recruitment

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