NCT06299553 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)
| NCT ID | NCT06299553 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Incyte Biosciences Italy S.r.l |
| Condition | DLBCL - Diffuse Large B Cell Lymphoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-12-04 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2023-12-04 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06299553 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying DLBCL - Diffuse Large B Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06299553 currently recruiting?
Yes, NCT06299553 is actively recruiting participants. Contact the research team at NBattaglia@incyte.com for enrollment information.
Where is the NCT06299553 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06299553 clinical trial?
NCT06299553 is sponsored by Incyte Biosciences Italy S.r.l. The trial plans to enroll 200 participants.