Primary Mediastinal Large B-cell Lymphoma. Clinical Trial
Official title:
A Phase II Study of SGN-35 (Brentuximab Vedotin) of Patients With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (PMLBCL)
Study Objectives Primary:
• To determine the antitumor efficacy of single-agent Brentuximab vedotin (1.8 mg/kg
administered intravenously every 3 weeks) as measured by the overall objective response rate
in patients with relapsed or refractory primary mediastinal large B-cell lymphoma.
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 Brentuximab vedotin
Additional:
• To assess disease-related symptoms
Number of Planned Patients 20 patients will be enrolled in this study. Duration of the study
The study duration is 18 months for enrollment and 2 years for the follow-up.
Study Population Eligible patients are those with relapsed or refractory primary mediastinal
large B-cell lymphoma. 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 Brentuximab vedotin or
previously received an allotransplant. In addition, 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.
Study Design This is a single-arm, open-label, multicenter, clinical trial to evaluate the
efficacy and safety of Brentuximab vedotin as a single agent in patients with relapsed or
refractory primary mediastinal large B-cell lymphoma.
Brentuximab vedotin 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. CT scans (chest, neck, abdomen, and pelvis) will be performed at
baseline and Cycles 2, 4, 7, 10, 13, and 16 and PET scans will be done at baseline and
Cycles 4 and 7. Patients will have an 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.
Test Product, Dose, and Mode of Administration Brentuximab vedotin, 1.8 mg/kg, administered
via outpatient IV infusion on Day 1 of each 21-day cycle.
Number of Planned Patients 20 patients will be enrolled in this study. Duration of Treatment
Brentuximab vedotin will be administered as a single IV infusion on Day 1 of each 21-day
cycle. Patients may continue on study treatment until disease progression or unacceptable
toxicity. Patients who achieve stable disease or better should receive a minimum of 8, but
no more than 16 cycles of study treatment.
Duration of the study The study duration is 18 months for enrollment and 2 years for the
follow-up. Efficacy Assessments Treatment response will be assessed by tumor imaging (spiral
CT of neck, chest, abdomen, pelvis and PET scans) performed at protocol-specified
timepoints. Determination of antitumor efficacy will be based on objective response
assessments made according to the Revised Response Criteria for Malignant Lymphoma. Clinical
response of progressive disease (PD), stable disease (SD), partial remission (PR), or
complete remission (CR) will be determined at each assessment. Responses will be determined
by investigator.
Safety Assessments Assessment of safety during the course of this study will consist of the
surveillance and recording of adverse events (AEs), recording of concomitant medication and
measurements of protocol-specified physical examination findings and laboratory tests.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment