Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
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 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.
- of seizure or convulsions, except history of childhood febrile seizures.
- Higher risk of seizure, as determined by the investigator (including, but not limited to, history of stroke; known Alzheimer’s disease or non-Alzheimer’s dementia; structural brain disease including arteriovenous malformations or other mass lesions; clinical diagnosis of traumatic brain injury or concussion within previous 6 months).
Patients on concomitant medications known to increase the risk of seizure may continue taking those medications, provided they have not previously experienced a seizure at or below the dose level being administered prior to initiation of GDC-8264.
Eligibility last updated 10/9/23. Questions regarding updates should be directed to the study team contact.