Phase III study in adults comparing inolimomab with standard of care in the treatment of acute graft versus host disease

• Conditions: Treatment of primary steroid refractory acute Graft versus Host Disease after allogeneic haematopoietic stem cell transplantation in adult patients; MedDRA version: 14.1Level: PTClassification code 10066260Term: Acute graft versus host diseaseSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2007-005009-24-BE
• Lead Sponsor: EUSA pharma SAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-12
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. age > or = 18 years
2. first allogeneic bone marrow or peripheral Stem Cell Transplantation from HLA-matched sibling donor or 10/10 HLA unrelated donor or 9/10 HLA donor for treatment of hematological malignancy or aplastic anaemia
3. patients can have received either a myeloablative or reduced-intensity conditioning regimen. Patients who have received a reduced-intensity conditioning regimen can be included if their first acute GvHD episode is within 6 months after the HSCT (within 100 days for the patients with standard myeloablative conditioning regimen)
4. patients 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, HL, myeloma, myeloproliferative diseases and myelodysplasia) from the underlying hematological malignancy at the time of SCT. Patients with aplastic anaemia requiring allogeneic transplantation.
5. GvHD prophylaxis with: short regimens (D1, D3 and D6 or D1, D3, D6 and D11) of methotrexate and cyclosporine or tacrolimus OR MMF (D-1 to D28) and cyclosporine (or tacrolimus) OR MMF (D-1 to D90) in case of HLA unrelated donor OR cyclosporine (or tacrolimus) alone for patients receiving in-vivo T-cells depleted graft (with ATG) OR Sirolimus at the following dosage: Day -3: 1 dose of 6 mg (upload dose); Day -2: 1 dose of 2 mg; then dose adaptation to reach values between 5-15 ng/ml and this to day 100 for related donors and to day 180 for MUD transplants. After that a gradual reduction to 0.
6. patient with the first episode of grade II to IV aGvHD (according to modified Glucksberg scoring system) developed within 100 days after HSCT and patients who have received a reduced-intensity conditioning regimen if their first acute GvHD episode is within 6 months after the HSCT (within 100 days for the patients with standard myeloablative conditioning regimen)
7. patient who already received MP (2mg/kg) as treatment and must have shown a resistance as defined by one of the following items: GvHD progressing after 3 days of MP treatment OR GvHD persisting after 7 days of MP treatment OR During the decrease of corticosteroids, in case of rebound of GvHD with grade equal or greater than II and as the dose of corticosteroids is still equal or more than 1 mg/kg/D
8. male and female patients must observe adequate birth control measures
9. patients must give written informed consent before completing any study related procedure which means assessment or evaluation that would not form part of the normal medical practice 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 63
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

1. post donor lymphocyte infusion GvHD
2. During the decrease of corticosteroids, in case of rebound of GvHD with grade inferior to II and/or if the dose of corticosteroids is less than 1 mg/kg/D
3. non 9/10 or 10/10 HLA- matched donor(sibling or unrelated)
4. transplantation other than haematological malignancy
5. cord blood transfusion
6. patients who have received prophylactic regimens of GvHD with corticosteroids
7. patient on mechanical ventilatory support
8. progression of the malignancy at the time of inclusion
9. serum creatinemia >30 mg/l
10. patient with vasopressor treatment
11. uncontrolled infection(s) within 72 hours prior to study entry despite adapted treatment.Neither continuation of antibiotics for a controlled infection nor prophylactic/empiric antiobiotics warrant exclusion
12. pregnant or lactating females
13. use of any investigational drug for the treatment of acute GvHD within 14 days prior to study entry
14. any history of hypersensitivity/allergy to murine products and any other component of study drug
15. positive HIV serology
16. ECOG >3
17. ASAT or ALAT > 10xULN
18. Serum albumin < or = 15g/l
19. minor patient and those incapable of giving informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified