Neihulizumab (ALTB-168) in Patients With Steroid-refractory Acute Graft-versus-host Disease or Tr… (NCT03327857) | Clinical Trial Compass
CompletedPhase 1
Neihulizumab (ALTB-168) in Patients With Steroid-refractory Acute Graft-versus-host Disease or Treatment-refractory Acute Graft-versus-host Disease
United States37 participantsStarted 2018-05-31
Plain-language summary
A Phase I study to establish the pharmacokinetics, pharmacodynamics, safety and efficacy profiles of Neihulizumab in patients with steroid-refractory or treatment refractory acute graft-versus-host disease (SR/TR-aGVHD)
Who can participate
Age range12 Years
SexALL
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Inclusion criteria
✓. Patients must have clinical aGVHD and pathologic findings consistent with the diagnosis by biopsy of at least 1 involved site, and
✓. progressed after 3 days of treatment with methylprednisolone (MP) 2 mg/kg/day equivalent, or
✓. did not improve after 7 days of treatment with MP 2 mg/kg/day equivalent, or
✓. progressed to involve a new organ after treatment with MP 1 mg/kg/day equivalent for skin and upper gastrointestinal (GI) GVHD, or
✓. recurred during or after a steroid taper
✓. For single dose phase: Patients must have erythematous manifestations of cutaneous aGVHD. Characteristics of the rash must indicate active inflammation (red coloration) as distinct from resolving inflammation (brown coloration).
✓. For single dose phase: Providers and patients must be willing to defer new systemic or cutaneous topical treatment of aGVHD for at least 36 hr after administration of Neihulizumab.
✓. Patient must give informed consent and sign an approved consent form prior to any study procedures.
Exclusion criteria
✕. For single dose phase: Prior administration of anti-lymphocyte globulin or anti- thymocyte globulin for treatment of aGVHD.
✕. For multiple dose phase: Has received any systemic treatment in addition to corticosteroids for aGVHD.
✕. Stage 4 lower GI GVHD, defined by the presence of ileus, severe abdominal pain, or overt GI bleeding.
✕. Uncontrolled infections not responding to antimicrobial therapy or requiring intensive critical care or vasopressors.
✕. Evidence of end-organ cytomegalovirus (CMV) or adenovirus infection.
✕. Known to have adenovirus, or Epstein Barr virus (EBV) viremia from screening according to institutional standard practice. Patients receiving appropriate antiviral treatment for CMV, HHV6 or hepatitis viremia are eligible on a case-by-case basis.
✕. HIV infection or a known HIV-related malignancy.
✕. Tuberculosis, history of tuberculosis or a known positive Quantiferon test for tuberculosis.