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Phase II Trial of Natalizumab (Tysabri®) Plus Prednisone for Initial Therapy of Acute Graft Versus Host Disease (aGVHD) of the Gastrointestinal Tract

Information source: Dana-Farber Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Graft Versus Host Disease

Intervention: Natalizumab (Drug); Methylprednisolone (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Dana-Farber Cancer Institute

Official(s) and/or principal investigator(s):
Corey Cutler, MD, MPH, Principal Investigator, Affiliation: Dana-Farber Cancer Institute

Overall contact:
Corey Cutler, MD, MPH, Phone: (617) 632-3470, Email: cscutler@partners.org

Summary

This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug Natalizumab in treating Acute Graft versus Host Disease in the Gastrointestinal Tract.

Clinical Details

Official title: Phase II Trial of Natalizumab (Tysabri) Plus Prednisone for Initial Therapy of Acute Graft Versus Host Disease (aGVHD) of the Gastrointestinal Tract

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: GVHD-free survival rate

Secondary outcome:

GVHD Response Rate

GI aGVHD Response Rate

Overall Survival Rate

Rate of GVHD flares

Steroid dose at day 28, day 56, day 100, day 180 and one year after the first dose of Natalizumab is administered.

Rate of systemic infections

Detailed description: Natalizumab is a drug that was initially discovered as a treatment for autoimmune conditions. Natalizumab has been approved for use in patients with Multiple Sclerosis and Crohn's disease. In these diseases, the drug works to inhibit dysfunctional immune cells that are responsible for the symptoms seen in these diseases. Acute graft versus host disease is caused by a similar dysfunction of immune cells; Natalizumab is thought to inhibit these immune cells, similarly to how it does in Multiple Sclerosis and Crohn's disease. In this research study,the investigators are looking to see whether Natalizumab provides additional benefit to patients receiving standard treatment for acute graft versus host disease of the gastrointestinal tract. Participants who fulfill eligibility criteria will be entered into the trial to receive Natalizumab.

- Participant will receive a dose of the natalizumab through intravenous infusion.

- Scheduled Physical Examination at screening, during the week of first dose and at 28

days, 56 days, 100 days, 180 days and one year.

- Correlative Studies

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Participants must meet the following criteria on screening examination to be eligible

to participate in the study:

- Participants must have acute GVHD of the lower gastrointestinal tract as defined by

the clinical impression of the treating physician, requiring systemic treatment. Minimum criteria for GI GVHD includes diarrhea of greater than 500 mL/day. Biopsy of the GI tract is required for study entry and must confirm the diagnosis of acute GVHD. Stool samples to rule out infectious causes of diarrhea, including norovirus, Clostridium difficile and other clinically indicated infections must also be negative. Eligibility includes:

- Acute GVHD developing after allogeneic hematopoietic stem cell transplantation

(HSCT) using bone marrow, peripheral blood stem cells, or umbilical cord blood. Recipients of non-myeloablative, reduced intensity and myeloablative transplants are eligible.

- Patients who develop acute GVHD after donor lymphocyte infusion (DLI) are

eligible.

- There is no specified time window after day 0 of transplant as acute GVHD is

only defined by clinical manifestations.

- Patients must have experienced neutrophil engraftment after HSCT as defined by

absolute neutrophil counts ≥ 500 / µL × 3 consecutive measurements. Absolute neutrophil count (ANC) should be calculated using the standard formula (Neut + Bands)(WBC × 101).

- The presence of hepatic, upper GI and/or cutaneous acute GVHD is permitted.

- Steroids can be started up to 3 days prior to the administration of natalizumab.

- Age ≥ 18

- Ability to understand and the willingness to sign a written informed consent

document. Exclusion Criteria

- Participants who exhibit any of the following conditions at screening will not be

eligible for admission into the study:

- Patients with the entity of Acute/Chronic GVHD overlap syndromes.

- Requiring mechanical ventilation

- Vasopressor requirement

- Concurrent hepatic veno-occlusive disease (VOD) based on clinical examination

- Karnofsky performance status < 30

- Participants may not be receiving any other study agents for at least 7 days prior to

enrollment

- Prior use of natalizumab for any reason is not allowed

- Pregnant women are excluded from this study because of the potential teratogenic

effects of natalizumab. Because natalizumab enters breast milk, and the effect is unknown in infants, breastfeeding should be discontinued if the mother is treated with natalizumab.

Locations and Contacts

Corey Cutler, MD, MPH, Phone: (617) 632-3470, Email: cscutler@partners.org

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States; Recruiting
Corey Cutler, MD, MPH, Phone: 617-632-3470, Email: cscutler@partners.org
Corey Cutler, MD, MPH, Principal Investigator

Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Not yet recruiting
Yi-Ben Chen, MD, Phone: 617-726-1124, Email: yachen@partners.org
Yi-Ben Chen, MD, Principal Investigator

Additional Information

Starting date: January 2015
Last updated: June 9, 2015

Page last updated: August 23, 2015

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