A Phase 2A Study of ALXN1007 in Participants With Newly Diagnosed Acute Lower Gastrointestinal Graft-Versus-Host Disease

Stopped early · Phase 2

Conditions studied: Acute Graft-Versus-Host Disease, GIGVHD

In brief

The objectives of this trial were to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD) and efficacy of intravenous (IV) ALXN1007 in participants with acute graft-versus-host disease (GVHD) of the lower gastrointestinal (GI) tract.

Key facts

Study ID

NCT02245412

Run by

Alexion Pharmaceuticals, Inc.

People needed

25

Starts

2014-11-14

Expected to finish

2017-02-27

Last updated by the study team

2019-01-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must be males or females age 18 years or older.
• Participants with Stage 1 to 4 (per the Modified Keystone Grading Schema) acute GVHD of the lower GI tract, without signs of chronic GVHD, at the time of diagnosis, which developed in the first 180 days following allogeneic hematopoietic cell transplantation (HCT) using bone marrow, peripheral blood, or cord blood; or after preplanned donor lymphocyte infusion.
• Participants are willing to undergo or must have had an endoscopy of the upper and/or lower GI tract and biopsy to confirm GI GVHD.
• Participants must be receiving systemic corticosteroids.
• Participants with an absolute neutrophil count (ANC) >500/microliter (μL) at Screening.
• Participants and spouse/partner who are of childbearing potential must be using high effective contraception consisting of 2 forms of birth control (at least 1 of which much be barrier method) starting at Screening and continuing through the entire study (for at least 3 months after the last dose of ALXN1007 if study treatment is stopped early or participant withdraws consent).
• Male participants must not donate sperm during the Screening and Treatment periods, and for at least 3 months after the last dose of ALXN1007.
• Stage of acute GVHD of the lower GI tract will be determined using the Modified Keystone Grading Schema.

You may not qualify if…

• Participants with a body weight > 140 kg (for Cohorts dosing 20 mg/kg of ALXN1007 and higher only).
• Participants with signs and symptoms of chronic GVHD.
• Participants with an active uncontrolled infection.
• Participants who test positive for Clostridium difficile (C. difficile) at Screening.
• Participants with relapsed/persistent malignancy requiring rapid immune suppression withdrawal.
• Participants who received an unplanned (not part of the original transplant therapy plan) donor lymphocyte infusion.
• Participants who received previous systemic treatment for acute GVHD, except for a maximum of 3 days (72 hours) of 2 mg/kg corticosteroid therapy.
• Participants with unresolved veno-occlusive disease of the liver.
• Participants with creatinine clearance <40 milliliters (mL)/minute at Screening, as calculated by the Cockcroft-Gault formula.
• Participants known to be infected with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
• Participants known to have an uncontrolled thyroid disorder.
• Participants who are pregnant, breast feeding, or sexually active and unwilling to use effective birth control for the duration of the study.
• Participants who participated in any other investigational drug trial or had exposure to any other investigational agent, device, or procedure <4 weeks prior to Screening and throughout the entire trial, with the exception of investigational drugs administered prophylactically for cytomegalovirus (CMV) post allogeneic HCT.

Where it is running

• City of Hope — Duarte, California, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• University of Minnesota Medicine - Hematology, Oncology and Transplantation Office — Minneapolis, Minnesota, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Abramson Cancer Perelman Center for Advanced Medicine, University of Pennsylvania — Philadelphia, Pennsylvania, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• CHU de Grenoble - Hôpital Nord — Grenoble, Isere, France
• Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Centre François — Gironde, France
• Hôpital Saint-Louis — Paris, France

Full record on ClinicalTrials.gov

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