RecruitingNCT07609576

Infectious Complications in Hematological Patients Under Treatment With Bispecific Antibodies.

Multicenter Study Proposal: Infectious Complications in Hematological Patients Under Treatment With Bispecific Antibodies.


Sponsor

Infanta Leonor University Hospital

Enrollment

350 participants

Start Date

May 14, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Adult patients (≥18 years) diagnosed with hematologic malignancies (e.g., multiple myeloma, non-Hodgkin lymphoma) who are receiving treatment with bispecific antibodies.
  • Patients must have initiated BsAb therapy within 30 days prior to study enrollment.
  • Ability to provide informed consent.
  • 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.

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Locations(2)

University Hospital Infanta Leonor

Madrid, Madrid, Spain

Infanta Leonor University Hospital

Madrid, Madrid, Spain

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NCT07609576


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