Infectious Complications in Hematological Patients Under Treatment With Bispecific Antibod
This is a prospective, multicenter, observational cohort study involving patients with hematologic malignancies who are receiving bispecific antibody therapy. The primary objective of this study is to evaluate the incidence, type, and severity of infectious complications in hematologic patients undergoing treatment wit
| Condition(s) | Lymphoma Neoplasms, Myeloma Multiple, Severe Infection, CMV Reactivation, Biespecific Treatment, Biespecific |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | This is a prospective, multicenter, observational cohort study involving patients with hematologic malignancies who are receiving bispecific antibody therapy. The primary objective of this study is to evaluate the incidence, type, and severity of infectious complications in hematologic patients undergoing treatment with bispecific antibodies. Secondary objectives include identifying risk factors associated with infection, comparing infectious outcomes across different hematologic malignancies and BsAb types, and assessing the impact of infections on overall treatment outcomes. |
| Who can participate | Inclusion Criteria: 1. Adult patients (≥18 years) diagnosed with hematologic malignancies (e.g., multiple myeloma, non-Hodgkin lymphoma) who are receiving treatment with bispecific antibodies. 2. Patients must have initiated BsAb therapy within 30 days prior to study enrollment. 3. Ability to provide informed consent. 4. Severe infections will be recorded the first year, but infectious events past confirmed relapse or new treatments for the underlying disease will not be recorded. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Infanta Leonor University Hospital |
| Locations | Madrid, Madrid, Spain; Madrid, Madrid, Spain |
| Start date | 2026-05-14 |
| NCT ID | NCT07609576 |
| Official listing | https://clinicaltrials.gov/study/NCT07609576 |