Extracorporeal Photopheresis Treatment in acute and chronic Graft versus Host Disease

Extracorporeal Photopheresis Treatment in steroid refractory acute and chronic Graft versus Host Disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001550-14-DK

Enrollment

Unknown

Registered

2015-04-10

Start date

2015-06-09

Completion date

Unknown

Last updated

2016-10-10

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

Conditions

Acute and chronic Graft versus Host Disease (GVHD) MedDRA version: 18.1 Level: PT Classification code 10018651 Term: Graft versus host disease System Organ Class: 10021428 - Immune system disorders

Interventions

Trade Name: Uvadex Product Name: Uvadex Pharmaceutical Form: Solution for blood fraction modification INN or Proposed INN: methoxsalen Other descriptive name: METHOXSALEN Concentration unit: µg/ml mic

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with acute or chronic GVHD, that do not respond sufficiently to glucocorticoids. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8

Exclusion criteria

Exclusion criteria: Patients with contraindications for extracorporeal photopheresis. Patients with relapse of primary hematologic disease or activity in this.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of treatment with extracorporeal photopheresis in acute and chronic GVHD.;Secondary Objective: Not applicable;Primary end point(s): For acute GVHD: -Achiement of Partial Remission (PR), Very Good Partial Remission (VGPR) or Complete Remission (CR) - Time to PR,VGPR or CR - Change in dose of immunosuppresive medication and time to half the dose of steroid. - Freedom form treatment failure at 6 months For chronic GVHD: - Response at 3,6,9 and 12 months - Time to partiel or complete remission - Freedom from treatment failure at 6 months - REduction in steroid dose - Duration ECP treatment - Re-occurence of chronic GVHD after stopping ECP ;Timepoint(s) of evaluation of this end point: Acute GVHD: Evaluation weekly for 8 weeks and then in week 10, 6, 20 and 24 after initiation of treatment. Chronic GVHD: Evaluation every 3 months for the duration of treatment.	—

Measure

Time frame

Main Objective: To evaluate the effect of treatment with extracorporeal photopheresis in acute and chronic GVHD.;Secondary Objective: Not applicable;Primary end point(s): For acute GVHD: -Achiement of Partial Remission (PR), Very Good Partial Remission (VGPR) or Complete Remission (CR) - Time to PR,VGPR or CR - Change in dose of immunosuppresive medication and time to half the dose of steroid. - Freedom form treatment failure at 6 months For chronic GVHD: - Response at 3,6,9 and 12 months - Time to partiel or complete remission - Freedom from treatment failure at 6 months - REduction in steroid dose - Duration ECP treatment - Re-occurence of chronic GVHD after stopping ECP ;Timepoint(s) of evaluation of this end point: Acute GVHD: Evaluation weekly for 8 weeks and then in week 10, 6, 20 and 24 after initiation of treatment. Chronic GVHD: Evaluation every 3 months for the duration of treatment.

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Secondary

Measure	Time frame
Secondary end point(s): Acute GVHD: - Duration of response - Duration of immunosuppressive treatment - Infections demanding antibiotics - Incidence of cGVHD (in the acute GVHD part) - Non-relapse mortality - Overall survival - Effect on chimerism for patients with non-myeloablative conditioning - amount and distribution of T-, B- and NK-cells (acute GVHD) Chronic GVHD: - Patient self assesment score - Occurence of infections - NIH global assesment score (2005) - Occurrence of relapse of primary hematologic disease - Chronic GVHD- free survival - Overall survival - Transplant related mortality - ;Timepoint(s) of evaluation of this end point: Most secondary endpoints will be assesed at the above mentioned timepoints. Non.relapse mortality ans overall survival will be assesed at the end of trial. T-,B- and NK cells + chimerism will be measured at the begining of treatment and at week 4 and 8.	—

Measure

Time frame

Secondary end point(s): Acute GVHD: - Duration of response - Duration of immunosuppressive treatment - Infections demanding antibiotics - Incidence of cGVHD (in the acute GVHD part) - Non-relapse mortality - Overall survival - Effect on chimerism for patients with non-myeloablative conditioning - amount and distribution of T-, B- and NK-cells (acute GVHD) Chronic GVHD: - Patient self assesment score - Occurence of infections - NIH global assesment score (2005) - Occurrence of relapse of primary hematologic disease - Chronic GVHD- free survival - Overall survival - Transplant related mortality - ;Timepoint(s) of evaluation of this end point: Most secondary endpoints will be assesed at the above mentioned timepoints. Non.relapse mortality ans overall survival will be assesed at the end of trial. T-,B- and NK cells + chimerism will be measured at the begining of treatment and at week 4 and 8.

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Countries

Denmark

Contacts

Public ContactMarietta Nygaard

Bispebjerg hospital

marietta.nygaard@regionh.dk004521494386

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026