Safety Study of Preimplantation Factor (PIF-1) to Treat Acute Steroid-Resistant Graft-Versus-Host Disease (GVHD)

NCT00517907 | Unknown Phase 1

• 1 other identifier: PIF1BMT-HMO-CTIL
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of this study is to determine the safety and tolerability of a novel peptide - preimplantation factor (PIF-1) - in patients who develop acute steroid-resistant graft-versus-host disease (GVHD) after matched bone marrow transplant (BMT). Following matched BMT, patients will be placed on standard GVHD preventive therapy (cyclosporine); those who do not respond to cyclosporine are placed on a high-dose steroid regimen for 3 days. Patients that do not respond to this standard treatment will be given PIF-1 subcutaneously for 14 days. Clinical data and samples will be collected, during PIF-1 administration and for an additional three months thereafter, to examine the long-term effect of PIF-1 treatment on the patients' GVHD status.

Conditions

Graft Vs Host Disease

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of PIF-1 in steroid-resistant patients who develop acute GVHD, as evidenced by clinical and laboratory indices

  within 90 days after first PIF-1 injection

Secondary Outcomes (1)

• Therapeutic effect of PIF-1 on participants' acute GVHD status, as determined by comparison with the clinical and laboratory indices before intervention

  within 90 days after first PIF-1 injection

Study Arms (1)

1

EXPERIMENTAL

6 steroid-resistant acute GVHD patients, post-matched BMT (serial)

Drug: Preimplantation factor (PIF-1)

Interventions

Preimplantation factor (PIF-1) DRUG

The study will include 6 patients and will last for at least six months. The first three patients will receive PIF-1 (0.5 mg/kg/day for 14 days) by subcutaneous injection. The dosage in the next three patients may be increased to 1 mg/kg/day for 14 days. Patients will be treated serially: each patient will be followed for 2 weeks after cessation of PIF-1 administration before the next patient begins PIF-1 administration.

1

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute steroid-resistant GVHD post matched BMT

You may not qualify if:

• Morbidity unrelated to GVHD

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• BioIncept LLC: collaborator

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Reuven Or, MD

  Bone Marrow Transplantation, Cancer Immunotherapy & Immunobiology Research Center, Hadassah University Hospital, Ein Kerem, Jerusalem, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reuven Or, MD

CONTACT

+972-2-677-8357; reuvenor@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 16, 2007
• First Posted: August 17, 2007
• Study Start: January 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: June 11, 2015

Record last verified: 2008-08

Locations

IL (1)