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Safety Follow-up of Treatment With Remestemcel-L in Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute GVHD
Phase 3 trial testing Remestemcel-L in Grade B Acute Graft Versus Host Disease in 32 participants. Completed in 15 June 2018.
| Lead sponsor | Mesoblast, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 32 |
| Start date | 28 October 2015 |
| Primary completion | 15 June 2018 |
| Estimated completion | 15 June 2018 |
| Sites | 20 locations across United States |
Mesoblast, Inc. — full company profile →
Adults 2 Months to 17, any sex, with Grade B Acute Graft Versus Host Disease or Grade C Acute Graft Versus Host Disease. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The overall survival rate is defined as the percentage of participants alive at the given time point. OS is defined as the time to death from the start of drug therapy.
| Group | Value | 95% CI |
|---|---|---|
| Remestemcel-L | 68.5 |
The overall survival rate is defined as the percentage of participants alive at the given time point. OS is defined as the time to death from the start of drug therapy.
| Group | Value | 95% CI |
|---|---|---|
| Remestemcel-L | 78.9 |
Time frame: Baseline (Day 100) up to Day 180 in Study MSB-GVHD002. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Remestemcel-L |
|---|---|---|
| Pneumonia | Infections and infestations | — |
| Septic shock | Infections and infestations | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — |
| Pneumatosis intestinalis | Gastrointestinal disorders | — |
| Haematochezia | Gastrointestinal disorders | — |
| Oedema peripheral | General disorders | — |
| Cholecystitis | Hepatobiliary disorders | — |
| Bacteraemia | Infections and infestations | — |
| Bronchopulmonary aspergillosis | Infections and infestations | — |
| Enterococcal infection | Infections and infestations | — |
| Nocardiosis | Infections and infestations | — |
| Osteomyelitis acute | Infections and infestations | — |
| Pneumonia pneumococcal | Infections and infestations | — |
| Pseudomonas infection | Infections and infestations | — |
| Vulval abscess | Infections and infestations | — |
| Laceration | Injury, poisoning and procedural complications | — |
| Weight decreased | Investigations | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — |
| Hypoalbuminaemia | Metabolism and nutrition disorders | — |
| Hyponatraemia | Metabolism and nutrition disorders | — |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | — |
| Acute lymphocytic leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Post transplant lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Eczema | Skin and subcutaneous tissue disorders | — |
Most-reported serious reactions: Pneumonia, Septic shock, Febrile neutropenia, Thrombocytopenia, Pneumatosis intestinalis, Haematochezia, Oedema peripheral, Cholecystitis.
Data from ClinicalTrials.gov NCT02652130 adverse events section.
Ongoing safety assessment follow-up to Protocol MSB-GVHD001 (NCT02336230) of remestemcel-L treatment in pediatric participants with acute graft versus host disease (aGVHD), following allogeneic hematopoietic stem cell transplant (HSCT), that have failed to respond to treatment with systemic corticosteroid therapy.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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