For treatment of patients with Primary Steroid Resistant Acute Graft versus Host Disease (aGvHD) following allogeneic Stem Cell Transplantation for Hematological Malignancies in Adult patients MedDRA version: 8.1 Level: LLT Classification code 10018651 Term: Graft versus host disease
Conditions
Interventions
Product Name: LEUKOTAC® (Inolimomab)
Product Code: B-B10
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Inolimomab
CAS Number: 152981 – 31
Current Sponsor code: B-B10, BT 563
Other
Sponsors
OPi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 2. First allogeneic bone marrow or peripheral Stem Cell Transplantation from HLA-matched sibling donor or 10/10 HLA unrelated donor for hematological malignancy 3. Patient must have received either a myeloablative or non myeloablative regimen, but in any case with no ATG treatment. 4. Patient must be in Complete Remission or chronic Phase (concerning the CML) or in stable disease (concerning CLL, Low grade NHL and myeloma) from the underlying Hematological malignancy at the time of the SCT 5. 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. 6. Patient with the first episode of grade II to IV aGvHD (according to modified Glucksberg scoring system) developed within 100 days after HSCT 7. Patients 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; GvHD persisting after 7 days 8. Patient must observe adequate birth control measures 9.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: 1. Post Donor Lymphocyte infusion GvHD 2. Non HLA matched donor 3. Transplantation other than hematological malignancy 4. Cord Blood transfusion 5. Patients who have received conditioning regimen with ATG 6. Patient 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 creatininemia > 30 mg/l 10. Patient with Vasopressor treatment 11. 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 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 > 5xULN 18. Serum Albumin = 15 g/l 19. Minor patient and those incapable of giving informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the Overall Response Rate (CR + PR) at D29 after initiation of Inolimomab in patients with Primary steroid resistant Acute Graft versus Host Disease (aGvHD) after Allogeneic Hematopoietic Stem Cell Transplantation ;Secondary Objective: 1. To evaluate the duration of the response 2. To determine the best response (BR) and the median time to obtain the best response 3. To determine the effect of Inolimomab on the Transplant-Related Mortality (TRM) defined as mortality not related to the relapse of the initial disease 4. To determine the effect of Inolimomab on the survival rate and disease free survival at D100, 6 months and one year after the Stem Cell Transplantationo after the initiation of Inolimomab, 5. To determine the effect of Inolimomab on transplantation by assessing the incidence of chronic GvHD, infections (bacterial and fungal) and Post-Transplant Lymphoproliferative disease and relapse of haematological malignancy 6.To determine the patients viral status evolution (CMV and EBV reactivation and other virus) 7. Safety profile and presence of HAMAs 8. To study immunophenotypage during Inolimomab treatment, 9. To study PK of Inolimomab in 20 enrolled patients ;Primary end point(s): Overall Response rate at D29 defined from the total number of patients achieving Complete response and Partial response (CR+PR) as defined below. - Complete response (CR): resolution of all clinical and biological symptoms of aGvHD, - Partial response (PR): reduction by one or more level of grading in overall aGvHD score without additional therapy or worsening in other organ systems | — |
Countries
France
Outcome results
None listed