Standard II acute graft-versus-host disease following allogeneic stem cell transplantation
Conditions
Interventions
Trade Name: UVADEX
Pharmaceutical Form: Solution for blood fraction modification
INN or Proposed INN: Methoxsalen
Other descriptive name: METHOXSALEN
Concentration unit: µg/ml microgram(s)/millilitre
Sponsors
CHRU de Nancy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 - validation of the presence of peripheral or central venous access allowing to perform 2 ECP per week during 3 months; - Leucocytes > 1.5 G/L - Platelets > 30 G/L, Haematocrite > 27% (allowed transfusions) - Patient affiliated to a French Sécurité Social regimen - information consent form signed. 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 62 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: - acute GVHD of grade I - acute GVHD of grade > II (Gastro intestinal stage > 1 or hepatic involvement) ; - progressive hematologic disease at inclusion - uncontrolled ongoing infection at time of inclusion: bacterial or fungal infections, increasing CMV viral load. - HIV positivity or replicative HBV or HCV infection ; - Contraindications for UVADEX / photopheresis / stéroids - Pregnancy ; - Women of child bearing potentiel not using contaception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the probability of being free of treatment failure (probability of survival without relapse, additional line of treatment for aGVHD and systemic therapy for chronic GVHD) after 6 months of the acute GVHS treatement between the experimental group (steroids + ECP) and the control group (steroids alone).;Secondary Objective: -cumulative dose of steroids over time, -infections (bacteremia, septicemia, fungal infection and virus reactivation) at 6 months, -the incidence and severity of chronic GVHD (diagnosed and graded according to NIH criteria ), -non-relapse mortality (death due to any cause except relapse), -disease relapse (relapse is defined on the basis of morphological evidence of leukemic or lymphoma cells in the bone marrow or other sites), -the disease-free survival -the overall survival -health-related quality of life using the French validated FACT-BMT (version 4.0) -Immune reconstitution (T, B, NK, gammaglobulins) ;Primary end point(s): Probability of being free of treatment failure (probability of survival without relapse, additional line of treatment for aGVHD and systemic therapy for chronic GVHD) at 6 months after randomization.;Timepoint(s) of evaluation of this end point: at 6 months after the start of treatement (randomization) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 - the mean of the cumulative dose of steroids, 2 - the cumulative incidence rate of infections (bacteremia, septicemia, fungal infection and virus reactivation), 3 - the incidence and severity of chronic GVHD (diagnosed and graded according to NIH criteria) 4 - the incidence rate of non-relapse mortality (death due to any cause except relapse), 5 - the incidence of disease relapse (relapse is defined on the basis of morphological evidence of leukemic or lymphoma cells in the bone marrow or other sites), 6 - the disease-free survival 7 - the overall survival 8 - the mean scores of health-related quality of life using the French validated FACT-BMT (version 4.0) 9- Immune reconstitution (T lymphocytes, T CD4, TCD8, B, NK, and gammaglobulins);Timepoint(s) of evaluation of this end point: 1- randomization-1 month, 1-2 month, 2-3 month, 3-6 month and 6-12 month periods 2- at 6 et 12 months 3- at 6 and 12 months, 4- at 6 and 12 months 5- at 6 and 12 months 6- at 6 and 12 months (time from transplantation to either first relapse or death in complete remission), 7- at 6 and 12 months (time from transplantation to death from any cause), 8- at 3, 6 and 12 months, 9- at 3, 6 and 12 months, | — |
Countries
France
Contacts
Public ContactVéronique SAUNIER
CHRU de Nancy
Outcome results
None listed