NCT03373305

Brentuximab Vedotin and Lenalidomide in Treating Patients With Relapsed or Refractory T-Cell Lymphomas

A Phase 1 Trial of Brentuximab Vedotin Plus Lenalidomide in Patients With Relapsed/ Refractory Cutaneous T-Cell Lymphomas

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of lenalidomide when given together with brentuximab vedotin in treating patients with T-cell lymphomas 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 lymphomas.

Detailed description

PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD)/Recommended Phase 2 dose (RP2D) of brentuximab vedotin in combination with lenalidomide in patients with relapsed/ refractory cutaneous T-cell lymphoma (CTCL). II. Assess safety and tolerability of brentuximab vedotin in combination with lenalidomide in patients with relapsed/ refractory CTCL. SECONDARY OBJECTIVES: I. Estimate the rate of objective global response that lasts at least 4 months (ORR4) , complete response (CR) rate, progression-free survival (PFS) of brentuximab vedotin in combination with lenalidomide in patients with relapsed/ refractory CTCL. II. Estimate the rate and duration of clinically meaningful reduction in pruritus (CMRP). III. Correlate response to baseline CD30 levels in tissue samples. TERTIARY OBJECTIVES: I. Estimate the response endpoints incorporating Lugano response criteria for patients with PET+ disease. II. Explore temporal gene expression profile in skin/ blood samples that may predict response to combination therapy. OUTLINE: This is a dose-escalation study of lenalidomide. Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1 and lenalidomide orally (PO) once daily (QD) on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then up to 12 months.

Conditions

• CD30-Positive Neoplastic Cells Present
• Folliculotropic Mycosis Fungoides
• Recurrent Mycosis Fungoides
• Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
• Refractory Mycosis Fungoides
• Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
• Sezary Syndrome

Interventions

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

Timeline

• Start date: 2019-03-01
• Primary completion: 2019-04-26
• Completion: 2019-04-26
• First posted: 2017-12-14
• Last updated: 2019-04-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study