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ECP Combination Study

NCT05052385 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 319

Last updated 2024-03-28

No results posted yet for this study

Summary

Extracorporeal photopheresis (ECP) offers an alternative to standard immunosuppression and shows an immunomodulatory rather than an immunosuppressive effect, which is associated with less toxicities and side effects. Additionally ECP has been shown to allow tapering of steroids and immunosuppressant agents which should be a goal of GvHD therapy.

ECP has been used for the management of GvHD since first described in 1994 and as its use has continued over the decades. The treatment was incorporated into a number of guidelines as a second line therapy in steroid refractory or steroid dependent GvHD patients. As well as being used in addition and after steroids, it is also used in combination with CNI Inhibitors, MMF and other immunosuppressant agents.

However, despite the current widespread use of ECP in the treatment of patients with GvHD, clinical data from randomized studies is limited and small prospective and retrospective trials are the main evidence base .This is also the case for other commonly used immunosuppressant agents, which have been used in GvHD since ECP was introduced.

The systematic review concluded that ECP is an effective therapy for oral, skin, and liver SR-cGVHD, with modest activity in lung and gastrointestinal SR-cGVHD.

In the USA Ibrutinib is the only FDA approved agent for second line cGvHD therapy once steroid therapy has failed and Ruxolitinib had been approved in the USA for the treatment of steroid refractory GvHD.

While studies have shown the effectiveness and safety of ECP in GvHD treatment, there is limited data to show how it is being used in combination with the recently approved agents.

Using existing registry data targeting centres where the newer agents are being used and enhancing the capture of treatment data we believe we can undertake a larger scale study, which will include the new treatment protocols. The aim of the current study is to improve the evidence basis on the potential benefit of ECP use as treatment of GVHD.

Conditions

  • Steroid Refractory GVHD

Interventions

DRUG

Ruxolitinib

As per treating physician's decision - non interventional study

DEVICE

Extracorporeal photopheresis

As per treating physician's decision - non interventional study

DRUG

Ibrutinib

As per treating physician's decision - non interventional study

Sponsors & Collaborators

  • Mallinckrodt

    collaborator INDUSTRY

  • European Society for Blood and Marrow Transplantation

    lead NETWORK

Principal Investigators

  • Olaf Penack, MD · European Society for Blood and Marrow Transplantation

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-13
Primary Completion
2022-06-15
Completion
2022-06-15
FDA Drug
Yes
FDA Device
Yes

Countries

  • Belgium
  • Denmark
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Poland
  • Romania
  • Russia
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05052385 on ClinicalTrials.gov