Infectious Complications in Hematological Patients Under Treatment With Bispecific Antibodies.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInfanta Leonor University Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

Myeloma or lymphoma patients undergoing biespecific treament

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Incidence of infections under biespecific treatment

to evaluate the incidence, type, and severity of infectious complications in hematologic patients undergoing treatment with bispecific antibodies.

Time frame
from enrollment to the end of treatment at 8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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