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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 as a treatment for Acute Myeloid Leukemia (AML) in combination with donor leukocyte infusion for patients with relapsed AML or myelodysplastic syndromes after allogeneic hematopoietic stem cell transplantation. It is currently in Phase 2 clinical development and is investigational, not yet approved for this indication.
Interferon gamma-1b is a small molecule that works by modulating the immune system. It is being evaluated in a Phase 2 trial for its potential to enhance the anti-leukemic effect of donor leukocyte infusion in patients with relapsed Acute Myeloid Leukemia and myelodysplastic syndromes after allogeneic stem cell transplantation.
Interferon gamma-1b is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. Amgen is conducting a Phase 2 clinical trial to evaluate this drug in patients with relapsed Acute Myeloid Leukemia and myelodysplastic syndromes.
Interferon gamma-1b is currently in Phase 2 clinical development for Acute Myeloid Leukemia. It is an investigational drug and has not been approved by the FDA for this use. The ongoing Phase 2 trial is actively recruiting participants in the United States.
Interferon gamma-1b is being studied in a Phase 2 clinical trial with the identifier NCT06529731. This trial is titled 'Interferon-γ (IFN-γ) With Donor Leukocyte Infusion to Treat Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndromes Post Allogeneic Hematopoietic Stem Cell Transplantation' and is currently recruiting 45 participants in the United States.
Yes, Interferon gamma-1b is also known as IFN-γ. The clinical trial NCT06529731 uses the name Interferon-γ (IFN-γ) to refer to this drug. It is being studied in combination with donor leukocyte infusion for the treatment of relapsed Acute Myeloid Leukemia and myelodysplastic syndromes after allogeneic stem cell transplantation.