Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas (NCT03220022)
A Pilot Study of Ibrutinib and R-da-EPOCH for Front Line Treatment of AIDS-Related Lymphomas
🩺 Plain-English Summary (8th-Grade Level)
This phase I trial studies the side effect and best dose of ibrutinib in combination with rituximab, etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride in treating patients with human immunodeficiency virus (HIV)-positive stage II-IV diffuse large B-cell lymphomas. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib and etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride may work better in treating patients with HIV-positive diffuse large B-cell lymphomas.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (25 items) and avoid the listed exclusions (21 items).
Location: UC San Diego Moores Cancer Center — La Jolla, California
Age range: 18 Years to 64 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:
- Participants who have had chemotherapy other than R-EPOCH, R-CHOP, or limited therapy, or radiotherapy other than palliative radiation for medical emergencies (like cord compression), within the last 4 weeks
- For the dose-finding cohort prior cytotoxic chemotherapy or radiotherapy for this lymphoma is exclusionary. For the dose-expansion cohort participants may have received:
- A maximum of one cycle of combination chemotherapy, including rituximab-containing regimens R-CHOP and R-EPOCH. The start of previous chemotherapy cycle must occur at least 21 days but no more than 28 days prior to beginning treatment under this protocol, and such cycle will count towards the maximum of 6 cycles under this study (i.e., cycle off study will count as cycle 1) OR
- 1 prior cycle of limited therapy including cyclophosphamide and/or rituximab and/or glucocorticoids to improve hepatic or renal function impaired due to lymphoma involvement. The start of this therapy may occur up to 28 days prior to beginning treatment under this protocol; cyclophosphamide administration must have been completed at least 14 days prior to initiation of protocol therapy. Such treatment will not count towards the maximum of 6 cycles under this study (i.e., participants will receive 6 cycles on study)
- For the dose-finding cohort rituximab within 12 months prior to study registration will be exclusionary; only exception will be if rituximab was given for indications other than the treatment of aggressive lymphoma. For the dose-expansion cohort one cycle of rituximab as part of R-CHOP or R-EPOCH or limited therapy may be administered off study prior to enrollment; prior rituximab will also be allowed if rituximab was given for indications other than the treatment of aggressive lymphoma
- Participants who are receiving any other investigational agents
- Participants who have previously received ibrutinib for another indication
- Expected survival \< 2 months
- Participants with a history of an opportunistic fungal infection or active fungal infection requiring, or at high risk of requiring, prophylactic or treatment with fluconazole, voriconazole or posaconazole
- Participants with known brain metastases from solid tumors should be excluded from this clinical trial
- Presence of second active tumor, other than non-melanoma skin cancer, carcinoma in situ of the cervix, or Kaposi's sarcoma (KS) that requires systemic therapy
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (19 Sites)
- UC San Diego Moores Cancer Center — La Jolla, California
- UCSF Medical Center-Parnassus — San Francisco, California
- University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida
- Memorial Hospital West — Pembroke Pines, Florida
- John H Stroger Jr Hospital of Cook County — Chicago, Illinois
- University of Illinois College of Medicine - Chicago — Chicago, Illinois
- Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland
- Boston Medical Center — Boston, Massachusetts
- Siteman Cancer Center at Washington University — St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri
- Mount Sinai Hospital — New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- Montefiore Medical Center - Moses Campus — The Bronx, New York
- Memorial Sloan Kettering Nassau — Uniondale, New York
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio
- Pennsylvania Hospital — Philadelphia, Pennsylvania
- Fox Chase Cancer Center — Philadelphia, Pennsylvania
- Virginia Mason Medical Center — Seattle, Washington
💰 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.
- 💵 Compensation indicated: Such treatment will not count towards the maximum of 6 cycles under this study (i.e., participants will receive 6 cycles on study) * For the dose-finding cohort rituximab within 12 months prior to ...
Explore by condition: All AIDS-Related 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.