Clinical trial NCT03198026: Obinutuzumab and Ibrutinib as Front Line Therapy in Treating Patients With Indolent Non-Hodgkin's Lymphomas
Official title: Phase II, Single Arm, Open Label Multi-center Study of Obinutuzumab and Ibrutinib in the Front Line Treatment of Indolent Non-Hodgkin's Lymphomas
Conditions: Non-Hodgkin's Lymphoma
Ann Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
Ann Arbor Stage II Follicular Lymphoma
Ann Arbor Stage II Nodal Marginal Zone Lymphoma
Ann Abor Stage III B-Cell Non-Hodgkin Lymphoma
Ann Arbor Stage III Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
Ann Arbor Stage III Follicular Lymphoma
Ann Arbor Stage III Nodal Marginal Zone Lymphoma
Ann Arbor Stage IV B-Cell Non-Hodgkin Lymphoma
Ann Arbor Stage IV Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
Ann Arbor Stage IV Follicular Lymphoma
Ann Arbor Stage IV Nodal Marginal Zone Lymphoma
Grade 1 Follicular Lymphoma
Grade 2 Follicular Lymphoma
Grade 3a Follicular Lymphoma
Indolent Non-hodgkin Lymphoma
Stage II Splenic Marginal Zone Lymphoma
Stage III Splenic Marginal Zone Lymphoma
Stage IV Splenic Marginal Zone Lymphoma
Summary: This phase II trial studies how well obinutuzumab and ibrutinib work as front line therapy in treating patients with indolent non-Hodgkin's lymphoma. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving obinutuzumab and ibrutinib may work better in treating patients with non-Hodgkin's lymphomas.
Interventions:
description: Given PO
name: Ibrutinib
other_name: 1-((3R)-3-(4-amino-3-(4-phenoxyphenyl)-1h-pyrazolo(3,4-d)pyrimidin-1-yl)-1-piperidinyl)-
2-Propen-1-one
936563-96-1
BTK Inhibitor PCI-32765
CRA-032765
Imbruvica
PCI-32765
type: Drug
description: Given IV
name: Obinutuzumab
other_name: 949142-50-1
Anti-CD20 Monoclonal Antibody R7159
GA-101
GA101
Gazyva
R7159
RO 5072759
RO-5072759
RO5072759
huMAB(CD20)
type: Biological
description: Correlative studies
name: Laboratory Biomarker Analysis
type: Other
Study arms:
design_group_description: Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab intravenously (IV) on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2 months after cycle 6, patients with stable disease will continue to receive obinutuzumab every 2 months for a total of 12 doses.<br/>After completion of study treatment, patients are followed up monthly for 1 year, every 3-6 months for 4 years, and then annually for up to 2 years.
design_group_title: Treatment (ibrutinib, obinutuzumab)
design_group_type: Experimental
Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators: Genentech, Inc.
Pharmacyclics LLC
Drug name mappings:
name: 伊布替尼
lang: CN
name: Ibrutinib
lang: EN
name: イブルチニブ
lang: JP
name: 奥妥珠单抗
lang: CN
name: Obinutuzumab
lang: EN
name: オビヌツズマブ（遺伝子組換え）
lang: JP