Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Graft Versus Host Disease in Skin Cutaneous T-Cell Lymphoma, Unspecified

Keywords

Photopheresis5-aminolevulinic acidExtracorporeal Circulation

Outcome Measures

Primary Outcomes (1)

Treatment safety: Monitored through recordings of ECG, vital signs and safety laboratory measurements including haematology, clinical chemistry and urinalysis.
Monitored through recordings of ECG, vital signs and safety laboratory measurements including haematology, clinical chemistry and urinalysis.
up to 1 year

Secondary Outcomes (2)

Main efficacy for CTCL
up to 1 year
Main efficacy for cGvHD
up to 1 year

Study Arms (1)

ALA-ECP

EXPERIMENTAL

Extracorporeal photopheresis (ECP) with 5-aminolevulinic acid replacing psoralen

Drug: ECP with 5-aminolevulinic acid

Interventions

ECP with 5-aminolevulinic acidDrug

extracorporeal photopheresis (ALA-ECP) using 5-aminolevulinic acid instead of psoralen (8-MOP) in a maximum of 10 treatment cycles

Also known as: 5-ALA

ALA-ECP

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Informed consent
cutaneous T-cell lymphoma (CTCL) (Mycosis fungoides and Sézary syndrome)

Sponsors & Collaborators

St. Olavs Hospital
Otherlead
Norwegian University of Science and Technology
Othercollaborator
Oslo University Hospital

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous

Interventions

Eosinophil Cationic ProteinAminolevulinic Acid

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

Vigleik Jessen, md
St Olavs Hospital, Trondheim Unversity Hospital
STUDY DIRECTOR
Torstein Baade Rø, md phd
Norwegian University of Science and Technology
STUDY DIRECTOR

Enrollment

7 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 6, 2017

First Posted

April 12, 2017

Study Start

September 20, 2017

Actual (reported)

Primary Completion

Modification of Extracorporeal Photopheresis in Cutaneous T-cell Lymphoma or Chronic Graft-versus-host Disease

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

ALA-ECP

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

ALA-ECP

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations