Obinutuzumab and Ibrutinib as Front Line Therapy in Treating Patients With Indolent Non-Hodgkin's Lymphomas (NCT03198026)
Phase II, Single Arm, Open Label Multi-center Study of Obinutuzumab and Ibrutinib in the Front Line Treatment of Indolent Non-Hodgkin's Lymphomas
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (39 items) and avoid the listed exclusions (29 items).
Location: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study:
- Prior history of malignancies unless the patient has been disease free for \>5 years. Exceptions include basal cell carcinoma or squamous cell carcinoma of the skin; carcinoma in situ of cervix; carcinoma in situ of breast, localized prostate cancer, or superficial bladder cancer that has undergone curative therapy.
- Prior therapy for lymphoma including chemotherapy or immunotherapy including ibrutinib/anti-CD20 agents.
- Corticosteroid use within 2 weeks prior to study treatment.
- Known prior significant hypersensitivity to obinutuzumab (not including infusion reactions) or Ibrutinib.
- Patients with evidence of large B cell transformation (transformed disease are not eligible).
- Known central nervous system (CNS) involvement by lymphoma
- Known bleeding disorders (e.g., von Willebrand's disease or hemophilia)
- Concomitant use of warfarin or other Vitamin K antagonists
- Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor (See Appendix 5).
- Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (related to the completion of the course of antibiotics) within 4 weeks before the start of cycle 1.
- Known infection with human immunodeficiency virus (HIV) or human T-cell leukemia virus 1 (HTLV-1) seropositive status
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Non-Hodgkin's Lymphoma
- Establishing a Tumor Bank in Families With Multiple Lymphoproliferative Malignancies — Boston, Massachusetts
- Activated T Lymphocytes Expressing CARs, Relapsed CD19+ Malignancies Post-Allo HSCT(CARPASCIO) — Houston, Texas
- PET Imaging of Cancer Patients Using 124I-PUH71: A Pilot Study — New York, New York
- A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma — Ann Arbor, Michigan
- Study to Evaluate Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-291 Moves Through the Body in Adult Participants With Non-Hodgkin's Lymphoma — Huntersville, North Carolina
Explore by condition: All Non-Hodgkin's Lymphoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.