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

Status: Recruiting
Location: See all (2) locations...
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Infanta Leonor University Hospital
RECRUITING
Madrid
University Hospital Infanta Leonor
RECRUITING
Madrid
Contact Information
Primary
maria stefania infante, MD, pHD
mariastefania.infante@salud.madrid.org
0034 608008118
Time Frame
Start Date: 2026-05-14
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 350
Related Therapeutic Areas
Sponsors
Leads: Infanta Leonor University Hospital

This content was sourced from clinicaltrials.gov