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

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)

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 angioimmunblastic T-cell lymphoma that has returned after a period of improvement (relapsed) or has not responded to previous treatment (refractory). Monoclonal antibodies, such as anti-ICOS monoclonal antibody MEDI-570, may block cancer growth in different ways by targeting certain cells.

Trial Description

Primary Outcome:

  • Incidence of toxicity and safety of MEDI-570, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0
  • Maximum tolerated dose (MTD) of MEDI-570
  • Recommended phase 2 dose of MEDI-570
Secondary Outcome:
  • Immunogenicity
  • Overall response rate, assessed per the Revised Response Criteria for Malignant Lymphoma of the Lugano Classification
  • Overall survival (OS)
  • Pharmacokinetics (PK), such as plasma concentration and PK parameters, of monoclonal antibody therapy
  • Progression-free survival
PRIMARY OBJECTIVES:
I. To determine the safety, maximum tolerated dose and recommended phase II dose (RP2D) of MEDI-570 (anti-ICOS monoclonal antibody MEDI-570) in patients with refractory/relapsed peripheral T-cell lymphoma (PTCL) follicular variant and angioimmunoblastic T-cell lymphoma (AITL). 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 tumour cells and response to MEDI-570. TERTIARY OBJECTIVES:
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 3 weeks for up to 12 courses 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.

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society