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)

NCT06299553 | Recruiting

• 1 other identifier: INCB88888-040 PRO-MIND
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

DLBCL - Diffuse Large B Cell Lymphoma

Keywords

Tafasitamab; Lenalidomide

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  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.

  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).

Secondary Outcomes (24)

• Baseline Characteristics

  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).

• Overall Response Rate (ORR)

  Visit in the 1° year (every 3 months) and visit in the 2°, 3°, 4° years (every 6 months).

• Duration of Response (DoR)

  Visit in the 1° year (every 3 months) and visit in the 2°, 3°, 4° years (every 6 months).

• Time to next treatment (TTNT)

  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).

• Time to response

  Visit in the 1° year(every 3 months) and visit in the 2°, 3°, 4° years (every 6 months).

Study Arms (1)

Single group/cohort

Patients with DLBCL R/R disease non-transplant eligible

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The enrollment will be done consecutively and starting from the list of patients identified in the Screening/Enrollment Log. Participating sites will be encouraged to enroll patients in a consecutive manner when patients come for their regular visit, in order to minimize bias in patient selection. At each participating site, the physician will assess patients to determine their eligibility for data collection within the study based on the selection criteria listed below. All patients will give their informed consent to participate in this study and will sign privacy disclosure before data collection is performed. All subjects documented are being treated according to local labeling specifications.The inclusion/exclusion criteria reflect the current approved Summary of Product Characteristics (SmPC) and AIFA monitoring registry.

You may qualify if:

• Patients are aged 18 years or older.
• Patients with DLBCL R/R disease non-transplant eligible.
• 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.
• Patients are able of giving the signed informed consent.

You may not qualify if:

• Concomitant participation in an interventional clinical study
• 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.
• Patients who started tafasitamab treatment before signing the ICF.

Sponsors & Collaborators

• Incyte Biosciences Italy S.r.l: lead
• Advice Pharma Group srl: collaborator

Study Sites (1)

Incyte Biosciences Italy S.r.l

Milan, 20122, Italy

RECRUITING

Related Publications (5)

• Zinzani 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 BACKGROUND

• Duell, 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

  BACKGROUND

• Calamia 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 BACKGROUND

• Aaronson 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 BACKGROUND

• van 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 BACKGROUND

MeSH Terms

Conditions

Dendritic Cell Sarcoma, Interdigitating

Condition Hierarchy (Ancestors)

Histiocytic Disorders, Malignant; Neoplasms by Histologic Type; Neoplasms; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Nicola Battaglia

CONTACT

+ 39 3429513636; NBattaglia@incyte.com

Mario Lapecorella

CONTACT

MLapecorella@incyte.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 8, 2024
• Study Start: December 4, 2023
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)