EUCTR2007-005009-24-FRActive, not recruitingPhase 1
An international randomised, multicentre, parallel-group, Phase III comparative study of inolimomab against usual care in the Treatment of Primary Steroid Refractory Acute Graft versus Host Disease (aGvHD) following allogeneic Stem Cell Transplantation in adult patients.
EUSA Pharma0 sites100 target enrollmentStarted: March 11, 2008Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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
- •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
- •ASAT or ALAT > 10xULN
- •Serum Albumin = 15 g/l
- •Minor patient and those incapable of giving informed consent
Investigators
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