Evaluating Tafasitamab with Lenalidomide for Relapsed DLBCL in Italy
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)
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Incyte Biosciences Italy S.r.l Industry-sponsored |
| Drugs / interventions | tafasitamab, tafasitmab |
| Locations | 1 site (Milan) |
| Trial ID | NCT06299553 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Milan
- Incyte Biosciences Italy S.r.l — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Nicola Battaglia
- Email: NBattaglia@incyte.com
- Phone: + 39 3429513636
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.