Avelumab, Utomilumab, Rituximab, Ibrutinib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT03440567
Phase
PHASE1
Status
Completed

Conditions

  • Recurrent Diffuse Large B-Cell Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma
  • Refractory Mantle Cell Lymphoma
  • Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Autologous Hematopoietic Stem Cell Transplantation — PROCEDURE
    Undergo autologous hematopoietic stem cell transplantation
  • Avelumab — DRUG
    Given IV
  • Carboplatin — DRUG
    Given IV
  • Etoposide Phosphate — DRUG
    Given IV
  • Ibrutinib — DRUG
    Given PO
  • Ifosfamide — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Rituximab — BIOLOGICAL
    Given IV
  • Utomilumab — BIOLOGICAL
    Given IV

Study Details

This phase I trial studies the side effects and best dose of avelumab, utomilumab, rituximab, ibrutinib, and combination chemotherapy in treating patients with diffuse large B-cell lymphoma or mantle cell lymphoma that has come back or does not respond to treatment. Monoclonal antibodies, such as avelumab, utomilumab, and rituximab, may interfere with the ability of tumor cells to grow and spread. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as etoposide phosphate, carboplatin, and ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving avelumab, utomilumab, rituximab, ibrutinib, and combination chemotherapy may work better in treating patients with diffuse large B-cell lymphoma or mantle cell lymphoma.

Key Dates

Start date
Apr 2, 2018
Status verified
Mar 2025
Primary completion
Jun 26, 2024
Completion
Jun 26, 2024

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort I (avelumab, utomilumab, RICE)
    Patients receive rituximab IV on day 1, etoposide phosphate IV on days 1-3, avelumab IV over 60 minutes on day 2, ifosfamide IV over 24 hours on day 2, and carboplatin IV on day 2 or rituximab IV on day 1, etoposide phosphate IV on days 1-3, avelumab IV over 60 minutes on days 2, utomilumab IV over 60 minutes on day 2, ifosfamide IV over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients may then undergo autologous hematopoietic stem cell transplantation.
  • Experimental: Cohort II (avelumab, utomilumab, rituximab, ibrutinib)
    Patients receive rituximab IV on day 1, avelumab IV over 60 minutes on days 2 and 16, and ibrutinib PO QD or rituximab IV on day 1, avelumab IV over 60 minutes on days 2 and 16, utomilumab IV on day 2, and ibrutinib PO QD. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. (Closed as of 12/12/2019)

Primary Outcome Measure

Maximum tolerated dose determined by dose-limiting toxicities [ Time Frame: Up to 21 days (cohort I) or 28 days (cohort II) ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-

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By research site
City of Hope Medical Center· Duarte, CA

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