Steroid refractory acute Graft versus Host Disease (aGvHD) after Allogeneic Haematopoietic Stem Cell Transplantation in adult patients MedDRA version: 9.1 Level: LLT Classification code 10018651 Term: Graft versus host disease
Conditions
Interventions
Product Name: LEUKOTAC (inolimomab)
Product Code: B-B10
Pharmaceutical Form: Solution for infusion
Sponsors
EUSA Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years • First allogeneic bone marrow or peripheral Stem Cell Transplantation from HLA-matched sibling donor or 10/10 HLA unrelated donor for treatment of haematological malignancy • Patient can have received either a myeloablative or reduced-intensity conditioning regimen • Patient must be in Complete Remission or in chronic Phase (concerning the CML) or at least in stable disease (concerning CLL, high and low grade NHL, myeloma and myelodysplasia) from the underlying haematological malignancy at the time of the SCT • GvHD prophylaxis with : Short regimens (D1, D3 and D6 or D1, D3, D6 and D11) of methotrexate and cyclosporine or tacrolimus or MMF (D1 to D28) and cyclosporine • Patient with the first episode of grade II to IV aGvHD (according to modified Glucksberg scoring system) developed within 100 days after HSCT • Patient who already received MP (2mg/kg) as treatment and must have shown a resistance as defined by one of the following item: GvHD progressing after 3 days of MP treatment GvHD persisting after 7 days of MP treatment • Male and female patients must observe adequate birth control measures. • Patient must give a written informed consent (personally signed and dated) before completing any study related procedure which means assessment or evaluation that would not form part of the normal medical care of the patient 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Post Donor Lymphocyte infusion GvHD • Patient with aGvHD progressing or persisting for more than 2 weeks after initiation of MP treatment • Non HLA matched donor • Transplantation other than haematological malignancy • Cord Blood transfusion • Patients who have received prophylactic regimens of GvHD with corticosteroids • Patient on mechanical ventilatory support • Progression of the malignancy at the time of inclusion • Serum creatininemia > 30 mg/l • Patient with vasopressor treatment • Uncontrolled infection(s), (i.e. documented bacterial, parasitical, or fungal infection) within 72 hours prior to study entry despite adapted treatment. Neither continuation of antibiotics for a controlled infection nor prophylactic/empiric antibiotics warrant exclusion • Pregnant or lactating females • Use of any investigational drug for the treatment of acute GvHD within 14 days prior to study entry • Any history of hypersensitivity/allergy to murine products and any other component of study drug • Positive HIV serology • ECOG > 3 • ASAT or ALAT > 10xULN • Serum Albumin = 15 g/l • Minor patient and those incapable of giving informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • To determine the Overall Response Rate (CR + PR) at D29 • To evaluate the duration of the response • To determine the effect of inolimomab and usual care on the survival rate at D100, 6 months after randomisation and 1 year post-transplant • To determine the effect of inolimomab and usual care on the Transplant Related Mortality and the Disease Free Survival at D100, 6 months and 1 year after randomisation • To determine the incidence of chronic GvHD, infections (bacterial and fungal) and Post-Transplant Lymphoproliferative disease and relapse of haematological malignancy • To determine the patients viral status evolution (CMV and EBV reactivation and other viral infections) • To determine the total amount of steroids used up to 1 year post randomisation • To determine the duration of hospital stay up to 1 year post randomisation • Safety profile and presence of HAMAs • To study pharmacokinetics of inolimomab ;Main Objective: Therapy success defined as overall survival at one year without replacement of the baseline allocated treatment ;Primary end point(s): Therapy success defined as overall survival at one year without replacement of the baseline allocated treatment | — |
Countries
Belgium, France
Outcome results
None listed