Clinical trial Recruiting at 1 site Observational Ages 18 and up

Evaluating Tafasitamab with Lenalidomide for Relapsed DLBCL in Italy

Official title: INCB88888-040 Multicenter Prospective Real-world Observational Cohort 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)

Run by Incyte Biosciences Italy S.r.l · NCT06299553 · Data updated 2026-11-12

This study is testing if a combination of two medications, tafasitamab and lenalidomide, can help people in Italy with relapsed diffuse large B-cell lymphoma who can't have a transplant.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorIncyte Biosciences Italy S.r.l
Industry-sponsored
Drugs / interventionstafasitamab, tafasitmab
Locations1 site (Milan)
StatusRecruiting
StartedDecember 4, 2023
Main results expectedJune 30, 2025
Study endsJune 30, 2027
Registry record updatedMay 22, 2024
Trial IDNCT06299553 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18 years or older with relapsed or refractory DLBCL who are not eligible for transplantation.

Probably not a fit

Patients who are currently participating in an interventional clinical study or who have started tafasitamab treatment before signing the informed consent form may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The PRO-MIND study is a multicenter, prospective observational cohort study conducted in Italy to assess the effectiveness and safety of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for transplantation. This study collects real-world data on treatment outcomes without mandating specific treatment protocols, allowing physicians to make decisions based on their clinical judgment. Patients will receive tafasitamab and lenalidomide through standard commercial channels, and the study aims to gather insights into the effectiveness of these treatments in a practical setting.

Why it matters

Potential benefit: If successful, this study could provide valuable information on the effectiveness of tafasitamab combined with lenalidomide for patients with relapsed DLBCL, potentially improving treatment strategies.

How similar studies have gone: While this study utilizes a combination of existing therapies, it is primarily observational and may provide insights that have not been extensively tested in similar real-world settings.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Incyte Biosciences Italy S.r.l
    Milan, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.