Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT03409432
Brief 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.
Study:
NCT03409432
Study Brief:
Protocol Section:
NCT03409432