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A Phase I Trial of MEDI-570 in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) Follicular Variant and Angioimmunoblastic T-Cell Lymphoma (AITL)
This phase I trial studies the side effects and best dose of anti-inducible T-cell co-stimulator (ICOS) monoclonal antibody MEDI-570 in treating patients with peripheral T-cell lymphoma follicular variant or angioimmunoblastic T-cell lymphoma that has returned after a period of improvement (relapsed) or has not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as anti-ICOS monoclonal antibody MEDI-570, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread.
PRIMARY OBJECTIVE: I. To determine the safety, maximum tolerated dose and recommended phase II dose (RP2D) of anti-ICOS monoclonal antibody MEDI-570 (MEDI-570) in patients with refractory/relapsed peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), follicular lymphoma, mycosis fungoides (MF) and cutaneous T-cell lymphomas (CTCL). SECONDARY OBJECTIVES: I. To evaluate the pharmacokinetic profile of MEDI-570. II. To evaluate the overall response rate (ORR) and progression free survival (PFS) of MEDI-570 at all dose levels and in a 10-patient expansion cohort at the maximum tolerated dose (MTD). III. To determine short and long term effects of MEDI-570 at all dose levels on the immune system and on T-cell lymphocyte subsets. IV. To determine the relationship between ICOS expression on tumor cells and response to MEDI-570. EXPLORATORY OBJECTIVE: I. To evaluate biomarkers of response and resistance to MEDI-570 in the study population. OUTLINE: This is a dose-escalation study. Patients receive anti-ICOS monoclonal antibody MEDI-570 intravenously (IV) over 1-4 hours on day 1. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 6 weeks for 12 weeks.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
City of Hope Comprehensive Cancer Center
Duarte, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Moffitt Cancer Center
Tampa, Florida, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
University of Kansas Clinical Research Center
Fairway, Kansas, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Start Date
September 13, 2016
Primary Completion Date
December 18, 2024
Completion Date
December 24, 2026
Last Updated
March 27, 2026
21
ACTUAL participants
Anti-ICOS Monoclonal Antibody MEDI-570
BIOLOGICAL
Laboratory Biomarker Analysis
OTHER
Pharmacological Study
OTHER
Lead Sponsor
National Cancer Institute (NCI)
NCT06859008
NCT02446457
Data Source & Attribution
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