Acute graft versus host disease
Conditions
Interventions
Part 1: Open-label, dose-finding phase (conducted outside Japan)
Cohorts 1 - 3: AAT 90 - 180 mg/kg to be administered intravenously as a loading dose on Day -1, followed by 60 - 120 mg/kg twice weekly
Sponsors
Akama Hideto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female participants, >=12 years of age (>= 18 years of age for participants at German sites only), undergoing HCT for hematological malignancies, including leukemia, lymphoma, multiple myeloma, myelodysplastic syndrome, and myeloproliferative neoplasms. 2. Planned myeloablative conditioning regimen. 3. Participants must have a related or unrelated donor as follows: - Related donor must be a 6 / 6 match for human leukocyte antigen (HLA)-A, -B, at intermediate (or higher) resolution, and -DR beta 1 (DRB1) at high resolution using deoxyribonucleic acid (DNA)-based typing. - Unrelated donor must be 7 / 8 or 8 / 8 match for HLA-A, -B, and -C at intermediate (or higher) resolution, and -DRB1 at high resolution using DNA-based typing.
Exclusion criteria
Exclusion criteria: 1. Prior autologous or allogeneic HCT. 2. T cell depleted transplant or planned use of anti-T cell antibody therapy either ex vivo or in vivo (ie, anti thymocyte globulin [ATG], alemtuzumab) for GVHD prophylaxis. 3. Planned umbilical cord blood transplant. 4. Planned use of cyclophosphamide after HCT for GVHD prophylaxis. 5. Planned haploidentical donor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade II-IV aGVHD-free survival through 180 days after HCT | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of lower gastrointestinal (GI) aGVHD or Grade III-IV aGVHD in any organ through 180 days after HCT 2. Incidence of severe infections defined by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) >= Grade 3 through 60 days after HCT 3. Incidence of Grade II-IV aGVHD or death through 100 and 180 days after HCT 4. Incidence of lower GI aGVHD through 60, 100, and 180 days after HCT 5. Incidence of severe infections defined by NCI-CTCAE >= Grade 3 through 100 and 180 days after HCT 6. Incidence of all-cause mortality, relapse-related and non-relapse-related mortality through 180, 365, and 730 days after HCT 7. Incidence of Grade III-IV aGVHD through 60, 100 and 180 days after HCT 8. Incidence of moderate to severe chronic GVHD through 180, 365, 545, and 730 days after HCT 9. Incidence of discontinuation of immune suppression through 180 and 365 days after HCT 10. Time to neutrophil engraftment 11. GVHD-relapse free survival through 365 and 730 days after HCT 12. Incidence of relapse of primary malignancies through 180, 365, and 730 days after HCT 13. Incidence of overall response, complete response and partial response among subjects with Grade II-IV aGVHD approximately 4 weeks after the initiation of systemic steroids during 8-week Treatment Period 14. Incidence of investigational product-related AEs 15. Pharmacokinetic parameters | — |
Countries
Australia, Germany, Italy, Japan, South Korea, Spain, Turkey, UK, US
Contacts
Public ContactHideto Akama
CSL Behring K.K.
Outcome results
None listed