Brentuximab Vedotin in the Elderly Hodgkin Lymphoma Patients at First Relapse or With Primary Refractory Disease.
Status:
Completed
Trial end date:
2020-04-01
Target enrollment:
Participant gender:
Summary
This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and
safety of BV as a single agent in elderly patients at first relapse or with primary
refractory HL.
BV will be administered as a single IV infusion on Day 1 of each 21-day cycle. Measures of
anti-cancer activity will be assessed using the revised response criteria for malignant
lymphoma (Cheson et al. 2007).
Computed tomography (CT) scans (chest, neck, abdomen, and pelvis) will be performed at
baseline and Cycles 4, 8, 12, and 16 and positron emission tomography (PET) scans will be
done at baseline and Cycles 4, 8, 12 and 16. Patients will have an End of Treatment (EOT)
assessment 30 ± 7 days after receiving their final dose of study drug. Long-term follow-up
assessments (including survival and disease status information) will be performed every 12
weeks until either patient death or study closure, whichever occurs first. Patients who
discontinue study treatment with stable disease or better will have CT scans done every 12
weeks until disease progression.
Study Objectives
Primary:
• To determine the antitumor efficacy of single-agent brentuximab vedotin (BV) (1.8 mg/kg
administered intravenously every 3 weeks) as measured by the overall objective response rate
in elderly patients at first relapse or with primary refractory Hodgkin lymphoma (HL).
Secondary:
- To assess duration of tumor control, including duration of response and progression-free
survival
- To assess survival
- To assess the safety and tolerability of BV
Additional:
• To assess disease-related symptoms Study Population Eligible patients are those with first
relapsed or primary refractory elderly HL. Patients must also have histologically-confirmed
CD30-positive disease, fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5
cm, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate
hematologic, kidney, and liver function. Eligible patients must not previously have been
treated with BV, patients must not have congestive heart failure, known cerebral/meningeal
disease, or any active viral, bacterial, or fungal infection requiring treatment with
antimicrobial therapy within 2 weeks prior to first study dose.