Anti-ICOS Monoclonal Antibody MEDI-570 in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma Follicular Variant or Angioimmunoblastic T-cell Lymphoma

Recurrent Grade 1 Follicular Lymphoma Clinical Trial

Official title: 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)

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Advanced Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
• Lymphoma
• Lymphoma, Follicular
• Lymphoma, Non-Hodgkin
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Lymphoma, T-Cell, Peripheral
• Mycoses
• Mycosis Fungoides
• Recurrence
• Recurrent Grade 1 Follicular Lymphoma
• Recurrent Grade 2 Follicular Lymphoma
• Recurrent Grade 3a Follicular Lymphoma
• Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
• Recurrent Mycosis Fungoides
• Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
• Refractory Grade 1 Follicular Lymphoma
• Refractory Grade 2 Follicular Lymphoma
• Refractory Grade 3a Follicular Lymphoma
• Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
• Stage IB Mycosis Fungoides AJCC v7
• Stage II Mycosis Fungoides AJCC v7
• Stage III Cutaneous T-Cell Non-Hodgkin Lymphoma
• Stage III Mycosis Fungoides AJCC v7
• Stage IV Cutaneous T-Cell Non-Hodgkin Lymphoma
• Stage IV Mycosis Fungoides AJCC v7

• NCT number: NCT02520791
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: September 13, 2016
• Completion date: February 28, 2025