Clinical trial · Observational
Infectious Complications in Hematological Patients Under Treatment With Bispecific Antibodies.
Multicenter Study Proposal: Infectious Complications in Hematological Patients Under Treatment With Bispecific Antibodies.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biespecific | — | UNRESOLVED | — |
| Biespecific Treatment | — | UNRESOLVED | — |
| CMV Reactivation | — | UNRESOLVED | — |
| Lymphoma Neoplasms | — | UNRESOLVED | — |
| Myeloma Multiple | Multiple Myeloma | ALIAS | 0.90 |
| Severe Infection | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence of infections under biespecific treatment
- timeFrame
- from enrollment to the end of treatment at 8 weeks
- description
- to evaluate the incidence, type, and severity of infectious complications in hematologic patients undergoing treatment with bispecific antibodies.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available