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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Incyte Biosciences Italy S.r.l Industry-sponsored |
| Drugs / interventions | tafasitamab, tafasitmab |
| Locations | 1 site (Milan) |
| Status | Recruiting |
| Started | December 4, 2023 |
| Main results expected | June 30, 2025 |
| Study ends | June 30, 2027 |
| Registry record updated | May 22, 2024 |
| Trial ID | NCT06299553 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
- Study coordinator: Nicola Battaglia
- Email: NBattaglia@incyte.com
- Phone: + 39 3429513636
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Orelabrutinib plus Pola-R-CHP as first-line treatment for intermediate- to high-risk DLBCL
This trial tests whether adding orelabrutinib to the Pola-R-CHP regimen can improve outcomes for adults with intermediate- to high-risk newly diagnosed DLBCL.
-
Hypofractionated Radiotherapy plus GM-CSF, Pomalidomide and Glofitamab for Newly Diagnosed PCNS-DLBCL
This study tests a combination therapy—hypofractionated radiotherapy with GM-CSF, pomalidomide, and glofitamab—for adults newly diagnosed with primary CNS DLBCL to see if it helps control the disease.
-
Modified DHAP vs Standard DHAP in relapsed/refractory DLBCL
This phase 3 trial tests whether a split, lower-dose version of DHAP is as effective as the standard regimen for adults with relapsed or refractory DLBCL and tries to reduce toxicities.
-
Tafasitamab and Rituximab for newly diagnosed follicular lymphoma
This study tests a combination of tafasitamab and rituximab to treat adults with newly diagnosed follicular lymphoma.
-
Orelabrutinib plus standard immunochemotherapy with or without auto-HSCT for newly diagnosed DLBCL
This study tests whether adding orelabrutinib to standard chemotherapy, with or without autologous stem cell transplantation, helps newly diagnosed DLBCL patients.
-
Tafasitamab plus Acalabrutinib and Venetoclax for newly treated CLL/SLL
This phase II study tests a combination of tafasitamab, acalabrutinib, and venetoclax in adults who are newly diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma to see if it is safe and effective.
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.