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Label indication ACTIMMUNE is indicated for reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD). ACTIMMUNE is indicated for delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO).
Also known as ACTIMMUNE®
Interferon gamma-1b · 1 trial · 2 indications
Occurrence of treatment failure, hematologic relapse from a CR (complete remission)/CRh/Cri), or death observed from start of IFN-γ treatment. Patients alive at 1 year after start of treatment will be censored on the date of last contact.
| Arm | Type | Description |
|---|---|---|
| IFN-γ + DLI | EXPERIMENTAL | ACTIMMUNE® (IFN-γ-1b) at a dose of 50 mcg/m\^2 (All participants will receive a 4-week period of IFN-γ monotherapy with ACTIMMUNE 100 mcg 3 times a week. This dose and schedule will be continued for 4 additional weeks and then tapered to 100 mcg weekly for an additional 4 weeks) DLI at a dose of 10\^7 CD3+ cells/kg (DLI doses will be given pending clinical assessment for disease, graft versus host disease (GVHD) and peripheral blood donor chimerism the week prior to DLI. Second DLI dose is only offered to subjects with residual disease not requiring cytotoxic therapy and without GVHD) |
| Name | Type | Description |
|---|---|---|
| Interferon gamma-1b | DRUG | ACTIMMUNE/Interferon gamma-1b is a single-chain polypeptide containing 140 amino acids that is produced by fermentation of a genetically engineered Escherichia coli bacterium containing the DNA which encodes for the recombinant protein. Interferon gamma-1b is part of a drug regimen used to treat Chronic Granulomatous Disease, or CGD. CGD is a genetic disorder, usually diagnosed in childhood, that affects some cells of the immune system and the body's ability to fight infections effectively. |
| Donor Leukocyte Infusion (DLI) | BIOLOGICAL | Donor lymphocyte infusion is a procedure that transfers healthy white blood cells (lymphocytes) from a bone marrow or stem cell donor to a recipient's blood. An infusion of healthy lymphocytes helps the recipient's immune system get rid of remaining cancer cells if they have a relapse after a bone marrow or stem cell transplant for blood cancer. |
Inclusion Criteria: 1. Age ≥ 18 years 2. Recipients of an alloSCT for AML or MDS from a minimally 8/8 HLA-matched donor 3. AML/MDS relapsed post-alloSCT with measurable residual disease defined by either of the following criteria: 1. At least 5% or more myeloblasts based on bone marrow biopsy m...
Interferon gamma-1b is being studied in Acute Myeloid Leukemia as an investigational treatment given together with donor leukocyte infusion for patients whose disease has relapsed after allogeneic hematopoietic stem cell transplantation. The Phase 2 study also enrolls patients with myelodysplastic syndromes. It is not an approved therapy for this use.
Interferon gamma-1b targets IFNG, the gene encoding interferon gamma. The drug is a form of interferon gamma, a cytokine that acts through the interferon gamma receptor to modulate immune cell activity. In this program it is combined with donor leukocyte infusion to stimulate an immune response against relapsed leukemia cells after transplant.
Amgen Inc. (ticker AMGN) is the developer of Interferon gamma-1b. The company is sponsoring the Phase 2 study evaluating the agent in combination with donor leukocyte infusion for relapsed Acute Myeloid Leukemia and myelodysplastic syndromes following allogeneic hematopoietic stem cell transplantation.
Interferon gamma-1b is in Phase 2 development for Acute Myeloid Leukemia. The program is investigational and has not been approved by the FDA for this indication. The single Phase 2 trial is currently recruiting participants and has a planned enrollment of 45 patients.
Interferon gamma-1b is being evaluated in the Phase 2 trial NCT06529731, titled Interferon-gamma (IFN-gamma) With Donor Leukocyte Infusion to Treat Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndromes Post Allogeneic Hematopoietic Stem Cell Transplantation. The study is recruiting in the United States, enrolls adults 18 years and older of any sex, and has a planned enrollment of 45 participants.