Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas

Conditions

• AIDS-Related Lymphoma
• Ann Arbor Stage II Diffuse Large B-Cell Lymphoma
• Ann Arbor Stage III Diffuse Large B-Cell Lymphoma
• Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 64 Years

Healthy Volunteers

Not accepted

Interventions

• Cyclophosphamide — DRUG
  Given IV
• Doxorubicin Hydrochloride — DRUG
  Given IV
• Etoposide — DRUG
  Given IV
• Filgrastim — BIOLOGICAL
  Given SC
• Ibrutinib — DRUG
  Given PO
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Pegfilgrastim — BIOLOGICAL
  Given SC
• Pharmacological Study — OTHER
  Correlative studies
• Prednisone — DRUG
  Given PO
• Rituximab — BIOLOGICAL
  Given IV
• Vincristine Sulfate — DRUG
  Given IV

Study Details

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.

Key Dates

Start date

Mar 16, 2018

Status verified

Jan 2026

Primary completion

Oct 10, 2024

Completion

Jul 16, 2026

Study Design

Enrollment

46 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (R-da-EPOCH)
  Patients receive rituximab IV on day 1 (for CD20 positive patients only), etoposide IV over 96 hours on days 1-4, doxorubicin hydrochloride IV over 96 hours on days 1-4, vincristine sulfate IV over 96 hours on days 1-4, prednisone PO daily on days 1-5, cyclophosphamide IV over 1 hour on day 5, and ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive pegfilgrastim SC from 1 calendar day up to 48 hours or filgrastim SC beginning on day 6 for up to 10 days until ANC is satisfactory.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Ibrutinib in Combination With Chemotherapy [ Time Frame: Up to 21 days ]

Locations (19)

Find similar trials in La Jolla, CA

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