NCT03605940

Brief Summary

Acute graft versus host-disease remains a major cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation. The incidence of grade II to IV acute GVHD ranges from 30 to 50% of the patients transplanted. Steroids remain the standard first line treatment for acute GVHD. Prolonged exposure to steroids is associated to increased risk of infections and of osteoporosis, osteonecrosis and alteration of growth in children. Thus, reducing steroid exposure in order to reduce treatment-related morbidity is another important goal in the management of standard risk aGVHD. Extracoporeal photopheresis (ECP) is active in controlling steroid refractory or dependent acute GVHD. Hypothesis: In this study, the team hypothesizes that addition of ECP to first line treatment with 2 mg/kg steroids of standard risk grade II aGVHD can reduce steroid exposure by increasing the probability of 6 month FFTF including absence of systemic steroids for chronic GVHD.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2018

Typical duration for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

July 30, 2018

Status Verified

July 1, 2018

Enrollment Period

2.5 years

First QC Date

July 21, 2018

Last Update Submit

July 27, 2018

Conditions

Acute-graft-versus-host Disease

Keywords

Acute-graft-versus-host DiseaseExtracorporal Photopheresis

Outcome Measures

Primary Outcomes (1)

  • Probability of being free of treatment failure (probability of survival without relapse, additional line of treatment for aGVHD and systemic therapy for chronic GVHD)

    6 months

Secondary Outcomes (16)

  • mean of the cumulative dose of steroids

    Month 1- Month 2 - Month 3 - Month 6 - Month 12

  • cumulative incidence rate of infections

    Month 6 - Month 12

  • cumulative incidence of thromboembolic complications

    Month 3

  • incidence of chronic GVHD

    Month 6 - Month 12

  • severity of chronic GVHD

    Month 6 - Month 12

  • +11 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

corticosteroids + ECP

Combination Product: Methoxsalen + ECP deviceDrug: Corticosteroids

Contrôl group

ACTIVE COMPARATOR

corticosteroids alone

Drug: Corticosteroids

Interventions

Methoxsalen + ECP deviceCOMBINATION_PRODUCT

2 sessions per week during 4 weeks and 1 session per week during 8 weeks

Experimental group
CorticosteroidsDRUG

2 mg/kg/day

Contrôl groupExperimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years ;
  • Having received an allogeneic stem cell transplantation for any malignant or non-malignant hemopathy and whatever the type of donor and graft.
  • with grade II acute GVHD with skin involvement (stage 1-3 skin +/- stage 1 gastro intestinal) in the 3 months following the allogeneic stem cell transplantation
  • acute GVHD in the first line treatment
  • Leucocytes \> 1.5 G/L
  • Platelets \> 30 G/L, Haematocrite \> 27% (allowed transfusions)
  • Patient affiliated to a French Social Security regimen
  • information consent form signed.

You may not qualify if:

  • acute GVHD of grade I
  • acute GVHD of grade \> II
  • patient with HIV positivity or replicative HBV or HCV infection
  • Contraindications for UVADEX / photopheresis / stéroids / posaconazole / heparin
  • Patient with a history of deep venous thrombosis
  • Pregnancy
  • Women of child bearing potentiel not using contaception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

MethoxsalenAdrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

FurocoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Marie-Thérèse RUBIO, PU-PH

CONTACT

0383153282m.rubio@chru-nancy.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2018

First Posted

July 30, 2018

Study Start

October 1, 2018

Primary Completion

April 1, 2021

Study Completion

April 1, 2022

Last Updated

July 30, 2018

Record last verified: 2018-07