Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00517907
Status:
UNKNOWN
Last Update Posted:
2015-06-11
First Post:
2007-08-16
Brief Title:
Safety Study of Preimplantation Factor PIF-1 to Treat Acute Steroid-Resistant Graft-Versus-Host Disease GVHD
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Phase I Clinical Trial to Assess Safety of Synthetic Preimplantation Factor PIF-1 in Patients With Steroid-Resistant Acute Graft-Versus-Host Disease GVHD After Allogeneic Hematopoietic Stem-Cell Transplantation
Status:
UNKNOWN
Status Verified Date:
2008-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIF1GVHD
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
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
Detailed Description:
Allogeneic BMT is a well-established treatment modality for malignant and non-malignant hematological diseases Mature donor T cells within the stem-cell graft are the main mediators of the beneficial immune effects but they are also responsible for the induction of GVHD which becomes the major cause of morbidity and mortality post-transplant Acute GVHD occurs within a 100-day period post-transplant and generally is manifested by dermatitis enteritis and hepatitis The treatment of GVHD continues to be a challenge To eliminate undesirable host-derived hematopoietic elements before BMT patients are traditionally treated with myeloablative conditioning regimens involving high-dose chemotherapy and total-body irradiation Standard GVHD prophylaxis and therapy comprise drugs that cause generalized immune suppression and place patients in danger of opportunistic infections and tumor relapse For acute GVHD prevention cyclosporine is often used however it is frequently necessary to administer long-term high-dose steroids as well
An acute GVHD patients lack of response to steroids is associated with poor prognosis The ideal prophylaxis treatment for BMT patients would be one that prevented the graft from attacking the host and that modulated the hosts immune response so that it would accept the transplant while maintaining its ability to protect the body against opportunistic hostile agents
Pregnancy is an immune paradox it allows maternal host acceptance of a semi-allograft embryo while it does not cause graft-versus-host or host-versus-graft reactions against the hostmother or immune suppression Therefore the pregnant immunological status is compatible with the desired immune profile in patients undergoing BMT By replicating the immune profile present in pregnancy in BMT patients we may be able to reduce the occurrence of GVHD-related morbidity and mortality rates
Preimplantation factor PIF-1 is a novel embryo-secreted peptide whose synthetic version matches the native peptides properties PIF-1 appears to play an important role in mediating the maternal response to pregnancy in mammals In preclinical studies PIF-1 has been found to be effective in preclinical BMT-GVHD models without apparent toxicity
An acute GVHD patients lack of response to steroids is associated with poor prognosis The ideal prophylaxis treatment for BMT patients would be one that prevented the graft from attacking the host and that modulated the hosts immune response so that it would accept the transplant while maintaining its ability to protect the body against opportunistic hostile agents
Pregnancy is an immune paradox it allows maternal host acceptance of a semi-allograft embryo while it does not cause graft-versus-host or host-versus-graft reactions against the hostmother or immune suppression Therefore the pregnant immunological status is compatible with the desired immune profile in patients undergoing BMT By replicating the immune profile present in pregnancy in BMT patients we may be able to reduce the occurrence of GVHD-related morbidity and mortality rates
Preimplantation factor PIF-1 is a novel embryo-secreted peptide whose synthetic version matches the native peptides properties PIF-1 appears to play an important role in mediating the maternal response to pregnancy in mammals In preclinical studies PIF-1 has been found to be effective in preclinical BMT-GVHD models without apparent toxicity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None