Infectious complications in blood cancer patients treated with bispecific antibodies
Official title: Multicenter Study Proposal: Infectious Complications in Hematological Patients Under Treatment With Bispecific Antibodies.
Run by Infanta Leonor University Hospital · NCT07609576 · Data updated 2026-11-12
This study tests how often infections occur in adults with blood cancers who are being treated with bispecific antibodies.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 350 (estimated) |
| Sponsor | Infanta Leonor University Hospital Academic / other |
| Locations | 2 sites (Madrid, Madrid and 1 other locations) |
| Status | Recruiting |
| Started | May 14, 2026 |
| Main results expected | June 15, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | May 27, 2026 |
| Trial ID | NCT07609576 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with hematologic malignancies who recently started bispecific antibody therapy (within 30 days) and can provide informed consent.
✕Probably not a fit
Patients not on bispecific antibodies or without active infection data may not benefit from insights related to BsAb-associated infections.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multicenter observational cohort enrolling adults with hematologic malignancies who are receiving bispecific antibodies. Data on infections, including type and severity, will be collected from European centers and analyzed to identify risk factors and differences across diseases and BsAb types. The study aims to understand how BsAbs may influence infection risk in real-world practice and how infections may affect cancer treatment outcomes. Data are collected anonymously through an online platform in compliance with data protection rules. The minimum planned sample size is 150–200 patients.
Why it matters
Potential benefit: If successful, the study could improve understanding of infection risk in patients receiving BsAbs and inform better infection prevention and management.
How similar studies have gone: Previous BsAb studies have shown productive use of real-world infection data, but specific infection risk profiles for BsAbs in hematologic patients are less well defined.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
University Hospital Infanta Leonor
Madrid, Madrid, Spain Recruiting -
Infanta Leonor University Hospital
Madrid, Madrid, Spain Recruiting
Study contacts
- Study coordinator: maria stefania infante, MD, pHD
- Email: mariastefania.infante@salud.madrid.org
- Phone: 0034 608008118
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.