NCT02871323

Durvalumab in Treating Patients With Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis

A Phase 1, Single Arm, Single Center Pilot Study of Medi4736, an Anti-Pdl1 Therapy, for Patients With Myelofibrosis

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this investigational research study is to determine how safe and tolerable the study drug, MEDI4736 (Durvalumab), is in patients with myelofibrosis (MF). The study drug belongs to a group of drugs called immune checkpoint inhibitors, which have shown promise in other forms of cancer, such as melanoma and lung cancer. One of the effects that this drug has is to activate the patient's own natural immune system. The purpose of this study is to examine the safety and tolerability of the study drug, to study how effective it is at treating patients with myelofibrosis, and to explore how certain markers in the patient's blood and/or bone marrow may be affected by the study drug.

Detailed description

PRIMARY OBJECTIVES: I. To determine the safety profile of anti-programmed cell death 1 ligand 1 (PDL1) therapy in patients with myelofibrosis. SECONDARY OBJECTIVES: I. Changes in MF symptom burden. II. Changes in spleen size. III. Blood and/or bone marrow samples. TERTIARY OBJECTIVES: I. To determine the rate of lymphocyte subset response to anti-PDL1 therapy, as measured by the percent increase in cluster of differentiation (CD)4+CD25+PD-L1+ T-lymphocytes and CD4+CD62L+CD127+ T lymphocytes in post-treatment peripheral blood samples. II. To characterize changes in the cytokine profile in response to anti-PDL1 therapy. III. To measure soluble PDL1 by enzyme-linked immunosorbent assay (ELISA) in post-treatment blood and/or bone marrow samples and programmed cell death-1 (PD1)/PDL1 by immunohistochemistry on bone marrow samples and correlate with treatment response. OUTLINE: Patients receive durvalumab intravenously (IV) over approximately 1 hour on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease (SD), no new inter-current illness, and no unacceptable toxicity, may continue treatment beyond 3 courses. Patients will be followed every 3 months for up to two years starting from Day 1.

Conditions

• Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase
• Primary Myelofibrosis

Interventions

Type	Name	Description
BIOLOGICAL	Durvalumab	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2016-11-01
• Primary completion: 2016-11-01
• First posted: 2016-08-18
• Last updated: 2019-08-20

Locations

1 site across 1 country: United States