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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Natalizumab and Prednisone or Methylprednisolone in Treating Participants with High Risk Acute Graft-Versus-Host Disease

This phase II trial studies how well natalizumab and prednisone or methylprednisolone work in treating participants with high risk acute graft-versus-host disease. Graft-versus-host disease is caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Immunotherapy with monoclonal antibodies, such as natalizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Prednisone and methylprednisolone are steroids that helps suppress the immune system and reduce inflammation. It is not yet known how well natalizumab and prednisone or methylprednisolone work in treating participants with high risk acute graft-versus-host disease.
Not Available
Phase II
Adults
Not Available
Not Available
Kitko, Carrie
National
Vanderbilt University
02-15-2017
Treatment
VICCPED1666
NCT02133924

Eligibility

18 Years
BOTH
NO
Inclusion Criteria:

New onset acute GVHD Ann Arbor score 2 or 3 following allogeneic bone marrow transplantation (BMT); any clinical severity (Glucksberg grade I-IV) is eligible; patients with prior or existing diagnosis of GVHD without any treatment are eligible; patients given only topical corticosteroids for skin GVHD are eligible

Any donor type (e.g., related, unrelated) or stem cell source (bone marrow, peripheral blood, cord blood); recipients of non-myeloablative and myeloablative transplants are eligible

No prior systemic treatment for acute GVHD except for a maximum of 3 days of prednisone (or IV methylprednisolone) =
Direct bilirubin must be
Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT)/alanine aminotransferase (ALT) serum glutamate pyruvate transaminase (SGPT) must be
If the patient is a woman of child-bearing potential, the patient and their sexual partner must agree to practice effective contraception

Written informed consent from patient or legal representative

Biopsy of acute GVHD target organ is strongly recommended but not required; enrollment should not be delayed for biopsy or pathology results; patients who do not enroll within 3 days of initiation of systemic steroid treatment for acute GVHD are not permitted to participate



Exclusion Criteria:

Patients with malignancy that is suspected or proven to have progressed, relapsed, or be persistent since progressive, relapsed or persistent malignancy documented since BMT

Uncontrolled active infection

Patients with chronic GVHD only; patients diagnosed with overlap syndrome are still eligible

History of or current diagnosis of progressive multifocal leukoencephalopathy (PML)

Pregnant or nursing (lactating) women

Use of other drugs for the treatment of acute GVHD

Steroid therapy for indications other than GVHD at doses > 0.5 mg/kg/d of methylprednisolone or equivalent within 7 days prior to initiation of GVHD treatment

Patients on dialysis

Patients requiring ventilator support

Investigational agent within 30 days of enrollment without approval from the sponsor- principal investigator (PI)

History of allergic reaction to natalizumab

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