PHASE II STUDY FOR THE TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE OF THE LIVER OR LUNGS WITH ADJUNCT EXTRACORPOREAL PHOTOIMMUNOTHERAPY

PHASE II STUDY FOR THE TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE OF THE LIVER OR LUNGS WITH ADJUNCT EXTRACORPOREAL PHOTOIMMUNOTHERAPY - nvt

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31393

Enrollment

Registered

2008-01-02

Start date

2007-10-01

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic graft-versus-host disease

Interventions

extracorporeal photopheresis

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Presence of at least one diagnostic clinical sign of chronic GVHD or an appropriate constellation of distinctive signs confirmed by biopsy or other relevant diagnostic tests;Presence of liver manifestation of chronic GVHD after allogeneic HSCT;Presence of lung manifestation of chronic GVHD after allogeneic HSCT (bronchiolitis obliterans either confirmed by lung biopsy or diagnosed via pulmonary function and radiology testing);Indication for systemic immunosuppressive therapy defined as chronic GVHD that involves three or more organs or with a score of 2 or greater in any single organ.

Exclusion criteria

Exclusion criteria: Patients with acute GVHD;Hypersensitivity or allergy to 8-methoxypsoralen;Hypersensitivity or allergy to both heparin and citrate products;Use of immunosuppressive medication other than CSA, FK506 and corticosteroids

Design outcomes

Primary

Measure	Time frame
GVHD response of the liver or lungs defined as response of liver or lung manifestations to first-line immunosuppressive treatment	—

Secondary

Measure	Time frame
Transplant-related mortality Relapse-free survival Overall survival Time to complete resolution of chronic GVHD to first-line immunosuppressive therapy Time to discontinuation of immunosuppressive treatment Duration of response to first-line immunosuppressive therapy Percent of patients in need of secondary treatment for chronic GVHD Response to secondary treatment for chronic GVHD Incidence of bacterial infections Incidence of viral infections Incidence of fungal infections Side effects of ECP	—

Measure

Time frame

Transplant-related mortality Relapse-free survival Overall survival Time to complete resolution of chronic GVHD to first-line immunosuppressive therapy Time to discontinuation of immunosuppressive treatment Duration of response to first-line immunosuppressive therapy Percent of patients in need of secondary treatment for chronic GVHD Response to secondary treatment for chronic GVHD Incidence of bacterial infections Incidence of viral infections Incidence of fungal infections Side effects of ECP

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)