Sezary Syndrome Clinical Trial
Official title:
A Phase 1 Trial of Brentuximab Vedotin Plus Lenalidomide in Patients With Relapsed/ Refractory Cutaneous T-Cell Lymphomas
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.
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.
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