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Clinical Trials in Italy / NCT06299553
Recruiting Observational

Study to Evaluate the Effectiveness of Tafasitamab in Combination With Lenalidomide Followed by Tafasitamab Monotherapy in Relapsed or Refractory Diffuse Large B-cell Lymphoma Non-transplant Eligible Patients in Italy (PRO-MIND)

NCT06299553 · tracked via the Priya Life Science Italy tracker
Sponsor
Incyte Biosciences Italy S.r.l
Phase
Observational
Started
2023-12-04
Last updated
2024-05-22

Condition(s) studied

DLBCL - Diffuse Large B Cell Lymphoma

Study summary

The PRO-MIND study is an Italian, multicenter, prospective observational cohort study to evaluate the effectiveness and the safety of tafasitamab in combination with lenalidomide followed by tafasitamab monotherapy in patient with DLBCL.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patients are aged 18 years or older. 2. Patients with DLBCL R/R disease non-transplant eligible. 3. Patients who will initiate the treatment with commercially available tafasitamab and lenalidomide after the ICF signature. The decision to prescribe tafasitamab must have been made prior and regardless of the enrollment of the patient in the study. 4. Patients are able of giving the signed informed consent. Exclusion Criteria: 1. Concomitant participation in an interventional clinical study 2. Any patient in the physician's opinion from whom initial diagnosis or follow-up data is unlikely to be obtained reliably data for the purposes of this observational study. 3. Patients who started tafasitamab treatment before signing the ICF.

Primary outcome measure(s)

  • Progression free survival (PFS) — At the beginning of Cycle 1 (day 1 of this cycle. The duration of each cycle is 28 days), visit in the 1° year (every 3 months) and visit in the 2°, 3°, 4° years (every 6 months).
    PFS is defined as the time from the date of treatment initiation until the first documented progression or relapse of disease measured by routine clinical care by the physician.

Trial sites (1)

FacilityCityRegionStatus
Incyte Biosciences Italy S.r.l Milan Italy Recruiting

Other trials for the same condition

An Italian Multicenter Retrospective Observational Study to Assess the Clinical Characteristics and the Outcome of Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma Treated With Polatuzumab Vedotin Plus Rituximab (± Bendamustine) Under Named Patient Programme Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06299553 on ClinicalTrials.gov ↗ ← All trials in Italy