NCT03409432

Brentuximab Vedotin and Lenalidomide in Treating Patients With Stage IB-IVB Relapsed or Refractory T-Cell Lymphoma

A Phase II Study of Brentuximab Vedotin and Lenalidomide in Relapsed and Refractory T-Cell Lymphomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: John Reneau · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well brentuximab vedotin and lenalidomide work in treating patients with stage IB-IVB T-cell lymphoma that have come back or do not respond to treatment. Monoclonal antibodies, such as brentuximab vedotin, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide, 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 brentuximab vedotin and lenalidomide may work better in treating patients with T-cell lymphoma.

Detailed description

PRIMARY OBJECTIVES: I. To determine the overall response rate (ORR) of the combination of brentuximab vedotin (BV) and lenalidomide in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL)/peripheral T-cell lymphoma (PTCL). SECONDARY OBJECTIVES: I. To estimate the duration of response and 2 year progression-free survival (PFS) and overall survival (OS) associated with the combination of brentuximab vedotin (BV) and lenalidomide in patients with relapsed or refractory CTCL/PTCL. II. To define the qualitative and quantitative toxicities of the combination of brentuximab vedotin (BV) and lenalidomide in patients with relapsed or refractory CTCL/PTCL. TERTIARY OBJECTIVES: I. To correlate between the expression of CD30 in neoplastic cells by immunohistochemistry (IHC) and overall response rate (ORR) of the combination of brentuximab vedotin (BV) and lenalidomide in patients with relapsed or refractory CTCL/PTCL. II. To determine T-cell and natural killer (NK) cell subset numbers, phenotype, and functional status in relapsed or refractory (rel/ref) CTCL/PTCL patients, and whether the combination of brentuximab vedotin and lenalidomide alters these parameters during therapy. III. To determine changes in plasma cytokine levels and other biomarkers in this patient population during therapy with the combination of brentuximab vedotin and lenalidomide. OUTLINE: Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1 and lenalidomide orally (PO) once daily (QD) on day 1-21. Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years.

Conditions

• Lymphomatoid Papulosis
• Primary Cutaneous Anaplastic Large Cell Lymphoma
• Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
• Recurrent T-Cell Non-Hodgkin Lymphoma
• Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
• Stage I Cutaneous T-Cell Non-Hodgkin Lymphoma
• Stage II Cutaneous T-Cell Non-Hodgkin Lymphoma
• Stage III Cutaneous T-Cell Non-Hodgkin Lymphoma
• Stage IV Cutaneous T-Cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Brentuximab Vedotin	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Lenalidomide	Given PO

Timeline

• Start date: 2018-03-16
• Primary completion: 2025-07-16
• Completion: 2025-07-16
• First posted: 2018-01-24
• Last updated: 2025-07-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study