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Also known as Roferon-A
Recombinant Interferon Alfa 2a · 1 trial · 3 indications
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship to the study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; Life-threatening experience (immediate risk of dying); Persistent or significant disability or incapacity; and congenital anomaly.
| Arm | Type | Description |
|---|---|---|
| Interferon Alfa-2A in Cancer Participants | EXPERIMENTAL | Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study will continue to receive the same treatment in this study. Pegylated interferon alfa-2A will be administered subcutaneously once weekly and recombinant interferon alfa 2A will be administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurs first (up to approximately 3 years). |
| Name | Type | Description |
|---|---|---|
| Pegylated Interferon Alfa-2a | DRUG | Participants will maintain the same dose they were receiving in the parent protocol. |
| Recombinant Interferon Alfa 2a | DRUG | Participants will maintain the same dose they were receiving in the parent protocol. |
Inclusion Criteria: * Participants must have completed protocol NO15753, NO15764, NO16006 or NO16007 and responded to treatment at the end of the trial as defined in the parent protocol * CML participants must have a confirmed cytogenetic complete response within 2 months of entering the extension ...
Recombinant Interferon Alfa 2a is an investigational biologic therapy developed by Roche Holding AG for certain cancers, including chronic myelogenous leukemia. It is an exogenous protein rather than a conventional small molecule, and it has been studied in a Phase 2 clinical trial in patients with chronic myelogenous leukemia and other malignancies.
Recombinant Interferon Alfa 2a has been studied for the treatment of chronic myelogenous leukemia, as well as malignant melanoma and renal cell carcinoma. Its development is focused in oncology, and it remains an investigational agent rather than an approved therapy for these indications.
Recombinant Interferon Alfa 2a is an exogenous protein whose molecular target is F9. Because it is an exogenous protein rather than a small molecule, it is designed to act through this protein target rather than through a conventional small molecule mechanism.
Recombinant Interferon Alfa 2a is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor behind the clinical development program for this investigational oncology agent.
Recombinant Interferon Alfa 2a is in Phase 2 clinical development. It is an investigational therapy and is not approved by the FDA for chronic myelogenous leukemia or any other indication based on the available development information.
Recombinant Interferon Alfa 2a has been evaluated in the Phase 2 trial NCT02829775, a completed study of continued treatment among participants who responded to peginterferon alfa-2a or recombinant interferon alfa-2a in prior clinical studies. That trial enrolled 9 participants across Bulgaria, Canada, India, Russia, Slovakia, South Africa, and Spain.
Yes. Recombinant Interferon Alfa 2a is also known as Roferon-A, and the Phase 2 trial NCT02829775 refers to it by that brand name. Searches for Roferon-A therefore refer to the same Roche investigational oncology agent.