Clinical trial · 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)
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)
NCT06299553CI-TRIAL-00077371recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DLBCL - Diffuse Large B Cell Lymphoma | Interdigitating Dendritic Cell Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Single group/cohort
- description
- Patients with DLBCL R/R disease non-transplant eligible
Primary outcomes (1)
- measure
- Progression free survival (PFS)
- timeFrame
- 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).
- description
- 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.
Secondary outcomes (24)
- measure
- Baseline Characteristics
- timeFrame
- Baseline, 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).
- description
- Demographics and clinical characteristics of patients receiving tafasitamab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDZinzani PL, Minotti G. Anti-CD19 monoclonal antibodies for the treatment of relapsed or refractory B-cell malignancies: a narrative review with focus on diffuse large B-cell lymphoma. J Cancer Res Clin Oncol. 2022 Jan;148(1):177-190. doi: 10.1007/s00432-021-03833-x. Epub 2021 Nov 6. PMID 34741682
- BACKGROUNDDuell, J., Abrisqueta, P., Andre, M., Augustin, M., Gaidano, G., Barca, E.G., Jurczak, W., Kalakonda, N., Liberati, A.M., Maddocks, K.J., Menne, T., Nagy, Z., Tournilhac, O., Bakuli, A., Amin, A., Gurbanov, K. and Salles, G. (2023), Five-year efficacy and safety of tafasitamab in patients with relapsed or refractory DLBCL: Final results from the Phase II L-MIND study. Hematological Oncology, 41: 437-439
- BACKGROUNDCalamia M, McBride A, Abraham I. Economic evaluation of polatuzumab-bendamustine-rituximab vs. tafasitamab-lenalidomide in transplant-ineligible R/R DLBCL. J Med Econ. 2021 Nov;24(sup1):14-24. doi: 10.1080/13696998.2021.2007704. PMID 34866523
- BACKGROUNDAaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365. PMID 8433390
- BACKGROUNDvan de Poll-Franse L, Oerlemans S, Bredart A, Kyriakou C, Sztankay M, Pallua S, Daniels L, Creutzberg CL, Cocks K, Malak S, Caocci G, Molica S, Chie W, Efficace F; EORTC Quality of Life Group. International development of four EORTC disease-specific quality of life questionnaires for patients with Hodgkin lymphoma, high- and low-grade non-Hodgkin lymphoma and chronic lymphocytic leukaemia. Qual Life Res. 2018 Feb;27(2):333-345. doi: 10.1007/s11136-017-1718-y. Epub 2017 Nov 10. PMID 29127596