Ibrutinib and Brentuximab Vedotin in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT02744612
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent Hodgkin Lymphoma
  • Refractory Hodgkin Lymphoma

Eligibility Criteria

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

Interventions

  • Brentuximab Vedotin — DRUG
    Given IV
  • Ibrutinib — DRUG
    Given PO

Study Details

This phase II trial studies how well ibrutinib and brentuximab vedotin work in treating patients with Hodgkin lymphoma that has returned (relapsed) or does not respond to treatment (refractory). Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as brentuximab vedotin, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving ibrutinib together with brentuximab vedotin may be a better treatment for Hodgkin lymphoma.

Key Dates

Start date
Jun 20, 2016
Status verified
Mar 2025
Primary completion
Mar 3, 2021
Completion
Jul 30, 2024

Study Design

Enrollment
39 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I: Ibrutinib 420 mg PO QD + BV 1.8 mg/kg IV Q21 days
    Patients receive ibrutinib 420 mg PO QD on days 1-21 and brentuximab vedotin 1.8 mg/kg IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm II: Ibrutinib 560 mg PO QD + BV 1.8 mg/kg IV Q21 days
    Patients receive ibrutinib 560 mg PO QD on days 1-21 and brentuximab vedotin 1.8 mg/kg IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Complete Response (CR) Rate [ Time Frame: Up to 8 months. ]

Locations (3)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-
NYP/Weill Cornell Medical CenterNew YorkNew York10065-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CANYP/Weill Cornell Medical Center· New York, NYOhio State University Comprehensive Cancer Center· Columbus, OH

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