Acute Graft-versus-host Disease Clinical Trial
Official title:
A Phase Ib, Open-label, Randomized, Dose-finding, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of GDC-8264 in Combination With Standard of Care in the Treatment of Acute Graft-versus-Host Disease in Patients Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation
Verified date | January 2024 |
Source | Genentech, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary purpose of the study is to assess the safety and pharmacokinetics (PK) of GDC-8264 in participants with acute graft-versus-host disease (aGVHD).
Status | Terminated |
Enrollment | 7 |
Est. completion date | January 15, 2024 |
Est. primary completion date | January 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Diagnosis of post-allogeneic hematopoietic stem cell transplantation (HSCT) aGVHD at screening - Evidence of engraftment post-transplant - Diagnosis of high-risk aGVHD, per refined Minnesota high-risk aGVHD criteria during screening - Initiation of treatment with systemic corticosteroids for aGVHD at a dose of prednisone =2 milligrams per kilograms per day (mg/kg/day) by orally (PO) or methylprednisolone =2 mg/kg/day intravenously (or equivalent) in divided doses at diagnosis and up to 3 days prior to or on the same day as initiation of GDC-8264 (Day 1), with no taper planned prior to Day 3 Exclusion Criteria: - Evidence of relapsed, progressing, or persistent malignancy, or treatment for relapse after transplant, or requirement for rapid immune suppression withdrawal as pre-emergent treatment of early malignancy relapse - Prior receipt of more than one allogeneic HSCT - Prior receipt of solid organ transplantation that are target organs for aGVHD (e.g., liver transplant) - Prior systemic treatment for aGVHD, except for the standard of care corticosteroid treatment initiated as part of this trial - Diagnosis of chronic GVHD or overlap syndrome - Uncontrolled active infection (i.e., progressive symptoms related to infection despite treatment, or persistently positive blood cultures despite treatment, or any other evidence of severe sepsis) - Severe organ dysfunction (e.g., acute liver failure, renal failure requiring dialysis, ventilator support, or vasopressor therapy) - Initiation or planned use of a marketed small molecule (excluding corticosteroids) or biologic therapy as treatment for aGVHD from the start of screening through the treatment period |
Country | Name | City | State |
---|---|---|---|
Canada | McMaster University Medical Centre | Hamilton | Ontario |
Canada | Princess Margaret Cancer Centre | Toronto | Ontario |
United States | Massachusetts General Hospital; Harvard Medical School - Gi Unit Grj724 | Boston | Massachusetts |
United States | City of Hope National Medical Center | Duarte | California |
United States | Columbia University Irving Medical Center | New York | New York |
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
United States | Abramson Cancer Center; Univ of Pennsylvania; PERELMAN CENTER FOR ADVANCED MEDICINE | Philadelphia | Pennsylvania |
United States | Mayo Clinic - PPDS | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Genentech, Inc. |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants with At Least One Adverse Events (AEs) and As per Severity of AEs | Screening up to end of study (up to approximately 3 years) | ||
Primary | Plasma Concentration of GDC-8264 | From Day 1 up to Day 57 | ||
Secondary | Overall Response Rate (ORR) | Up to Day 29 | ||
Secondary | Duration of Response (DOR) | From Day 29 up to end of study (up to approximately 3 years) | ||
Secondary | Percentage of Participants with aGVHD Flares | Baseline up to Day 56 | ||
Secondary | Percentage of Participants with Non-relapse Mortality (NRM) | Baseline up to Day 180 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02241018 -
MSCs Combined With CD25 Monoclonal Antibody and Calcineurin Inhibitors for Treatment of Steroid-resistant aGVHD
|
Phase 2/Phase 3 | |
Completed |
NCT04539470 -
Study to Evaluate the Safety and Pharmacokinetics of Efmarodocokin Alfa in Combination With Standard of Care in Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
|
Phase 1 | |
Terminated |
NCT02245412 -
A Phase 2A Study of ALXN1007 in Participants With Newly Diagnosed Acute Lower Gastrointestinal Graft-Versus-Host Disease
|
Phase 2 | |
Recruiting |
NCT02659657 -
Prophylaxis Roles of IL-2 Treatment on GVHD After Transplantation
|
Phase 2 | |
Completed |
NCT03497273 -
Safety of Itacitinib in Combination With Corticosteroids for Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Japanese Subjects
|
Phase 1 | |
Completed |
NCT05825833 -
Infliximab Efficacy in Relation to Therapeutic Drug Monitoring and Serum TNFα Levels in Pediatric HSCT
|
||
Not yet recruiting |
NCT06294678 -
Effect of Stem Cell Infusion Time on aGVHD in Patients With Hematological Malignancies
|
Phase 3 | |
Not yet recruiting |
NCT06294691 -
Effect of Stem Cell Infusion Time on aGVHD in Patients With Nonmalignant Hematologic Diseases
|
Phase 3 | |
Recruiting |
NCT04285424 -
FMT for Steroid Resistant Gut Acute GVHD
|
Early Phase 1 | |
Terminated |
NCT01903473 -
Donor Regulatory T Cells Infusion in Patients With Chronic Graft-versus-host Disease (GVHD)
|
Phase 2 | |
Recruiting |
NCT02044185 -
Clinical Implications of HMGB1 in Patients Treated With Chemotherapy or Hematopoietic Stem Cell Transplantation
|
N/A | |
Recruiting |
NCT01765634 -
Mesenchymal Stem Cells for Treatment of Refractory Acute Graft-versus-host Disease
|
Phase 2 | |
Terminated |
NCT00282503 -
Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Acute Graft Versus-Host Disease
|
Phase 3 | |
Recruiting |
NCT01521039 -
Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease
|
||
Terminated |
NCT03721965 -
Safety and Efficacy of Itacitinib in Combination With Corticosteroids for Treatment of Graft-Versus-Host Disease in Pediatric Subjects
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT04971551 -
A Study of Jaktinib for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.
|
Phase 2 | |
Completed |
NCT02743351 -
Study of ProTmune for Allogeneic HCT in Adult Patients With Hematologic Malignancies
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT06394895 -
Donor Neutrophil Subsets to Predict the Risk of aGVHD
|
||
Recruiting |
NCT02611180 -
Dendritic Cells in Patients With Acute or Chronic Skin Graft Versus Host Disease
|