EUCTR2019-000894-22-AT
Active, not recruiting
Phase 1
Phase II multicenter study of extracorporeal photopheresis with UvadexTM plus standard steroid treatment for high risk acute Graft-versus-Host Disease
Department of Stem Cell Transplantation - University Medical Center Hamburg-Eppendorf0 sites72 target enrollmentMay 24, 2022
Conditionsew onset high risk acute GvHD following allogeneic SCTMedDRA version: 20.0Level: LLTClassification code 10018653Term: Graft-versus-host disease <GVHD>System Organ Class: 10021428 - Immune system disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
DrugsUVADEX
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ew onset high risk acute GvHD following allogeneic SCT
- Sponsor
- Department of Stem Cell Transplantation - University Medical Center Hamburg-Eppendorf
- Enrollment
- 72
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. New onset high risk acute GvHD (Ann Arbor score 2/3 as defined in Appendix A) following allogeneic SCT. Any clinical severity (Glucksberg grade I\-IV) is eligible.
- •2\. 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.
- •3\. No prior systemic treatment for acute GvHD except for a maximum of 7 days of methylprednisolone \=2 mg/kg/day (or IV Methyprednisolone equivalent) during the period from the initiation of systemic steroid treatment for acute GvHD until study therapy begins. Topical skin steroid treatment and non\-absorbable oral steroid treatment for GI GvHD are permissible.
- •4\. Age 18 years or older.
- •5\. Platelet count \> 25\.000 (including platelet support)
- •6\. Eastern Coorperative Oncology Group (ECOG) score of 0\=2 unless due to aGvHD
- •7\. Negative pregnancy test within 10 days before start of study if the patient is a woman of child\-bearing age
- •8\. Direct bilirubin must be \<2 mg/dL unless the elevation is known to be due to Gilbert syndrome or aGvHD within 3 days before screening.
- •9\. ALT/SGPT and AST/SGOT must be \<5 x the upper limit of the normal range within 3 days before screening
- •10\. Females/Males who agree to comply with the applicable contraceptive requirements of the protocol (see section 11\).
Exclusion Criteria
- •1\. Progressive or relapsed malignancy
- •2\. Uncontrolled active infection
- •3\. Patients with chronic GvHD
- •4\. History of or current diagnosis of progressive multifocal leu\-koencephalopathy (PML)
- •5\. Pregnant or nursing (lactating) women
- •6\. Use of other drugs for the treatment of acute GvHD apart from on\-going GvHD prophylaxis and corticosteroids
- •7\. Patients on dialysis
- •8\. Patients requiring ventilator support
- •9\. Evidence of known infection with human immunodeficiency virus (HIV) or active hepatitis B
- •10\. Investigational agent within 30 days of enrollment without approval from the Sponsor\-Investigator (PI). (Off\-label use of medication is not considered investigational unless in context of a formal study)
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Phase II multicenter study of UV irradiation with UvadexTM outside of the body plus standard steroid treatment for high risk acute Graft-versus-Host Diseaseew onset high risk acute GvHD following allogeneic SCTMedDRA version: 20.0Level: LLTClassification code 10018653Term: Graft-versus-host disease <GVHD>System Organ Class: 100000004870Therapeutic area: Diseases [C] - Immune System Diseases [C20]EUCTR2019-000894-22-DEDepartment of Stem Cell Transplantation - University Medical Center Hamburg-Eppendorf72
Active, not recruiting
Phase 1
Imaging study evaluating the utility of pre-treatment zirconium-89 labelled trastuzumab PET/CT (Imaging of the membranair receptor HER2 with the tracer zirconium 89 trastuzumab) and an early FDG-PET/CT response (early metabolic assessment) to identify patients with HER-2 positive invasive carcinoma of the breast with locally recurrent (not amenable to resection with curative intent) or metastatic disease unlikely to benefit from a novel anti-HER2 therapy: T-DM1EUCTR2011-005437-39-BEJules Bordet Institute105
Active, not recruiting
Phase 1
Imaging study evaluating the utility of pre-treatment zirconium-89 labelled trastuzumab PET/CT (Imaging of the membranair receptor HER2 with the tracer zirconium 89 trastuzumab) and an early FDG-PET/CT response (early metabolic assessment) to identify patients with HER-2 positive invasive carcinoma of the breast with locally recurrent (not amenable to resection with curative intent) or metastatic disease unlikely to benefit from a novel anti-HER2 therapy: T-DM1ocally recurrent (not amenable to resection with curative intent) or metastatic disease scheduled for a first or any subsequent metastatic treatment lineMedDRA version: 19.0Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2011-005437-39-NLJules Bordet Institute105
Completed
Phase 2
A phase II prospective imaging study evaluating the utility of pre-treatment zirconium-89 labelled trastuzumab PET/CT and an early FDG-PET/CT response to identify patients with advanced HER-2 positive breast cancer unlikely to benefit from a novel anti-HER2 therapy: T-DM1HER2 positive breast cancerBreast cancer10006291NL-OMON43903Institut Jules Bordet55
Completed
Not Applicable
A comparative study of shock wave therapy and corticosteroid injection in the treatment of heel paiplantar fasciitis.Fibroblastic disordersIRCT201203069221N1Army University of Medical Sciences74