Obinutuzumab and Ibrutinib as Front Line Therapy in Treating Patients With Indolent Non-Hodgkin's… (NCT03198026) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Obinutuzumab and Ibrutinib as Front Line Therapy in Treating Patients With Indolent Non-Hodgkin's Lymphomas
United States30 participantsStarted 2018-02-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Previously untreated, histologically confirmed indolent non-Hodgkin's lymphoma as follows:
* Follicular lymphoma (World Health Organization \[WHO\] classification grade 1, 2, or 3a)
* Marginal zone lymphoma including:
* Nodal and splenic marginal zone lymphoma (MZL) who have an indication for systemic therapy
* Extranodal MZL:
* Nongastric/noncutaneous MZL requiring systemic therapy
* Cutaneous MZL will be eligible only if they have pathologically confirmed extra-cutaneous disease
* Gastric MZL only if stage IIIE/IV defined as lymph node involvement on both sides of the diaphragm or with disseminated extranodal disease such as bone marrow or additional extra nodal sites
* Pathological diagnosis should be obtained by incisional or excisional tissue biopsy; core biopsy is permissible if obtaining an incisional or excisional is not possible and if the grade can be assessed on the core biopsy; a core biopsy can also be used if deemed in the best interest of the patient in the opinion of the investigator
* Patients must have stage II-IV disease
* All patients should have measurable disease; measurable disease is defined as a lymph node or tumor mass that is \>= 1.5 cm in at least one dimension by computed tomography (CT) or the CT portion of the PET/CT
* Documentation of CD20+ status
* Patients must have an indication for therapy per standard modified Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria including:
* …
What they're measuring
1
Overall response rate in patients with newly diagnosed indolent lymphoma requiring treatment, including complete response and partial response
Timeframe: Up to 2 years
Trial details
NCT IDNCT03198026
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University