POLAR BEAR

Phase 1

Recruiting

• Conditions: Diffuse Large B-Cell Lymphoma; MedDRA version: 21.1Level: LLTClassification code: 10012857Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) refractory Class: 10029104; Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-502887-19-00
• Lead Sponsor: Region Skane

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-16
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 305

Inclusion Criteria

Age =80 years or frail =75 years, according to simplified comprehensive geriatric assessment, Histologically confirmed lymphoma belonging to one of the following subtypes: a. Diffuse large B-cell lymphoma, including transformation from an indolent lymphoma; b. Follicular lymphoma grade 3B; c. T-cell/histiocyte-rich LBCL; d. Primary cutaneous DLBCL, leg type; e. EBV-positive DLBCL, NOS; f. Primary mediastinal LBCL; g. High grade B-cell lymphoma with MYC/BCL2 rearrangement, Stage II-IV disease, At least 1 measurable site of disease (>1.5 cm long axis), No previous treatment for lymphoma, WHO performance status 0 – 3 (Grade 3 if related to DLBCL), Written informed consent

Exclusion Criteria

Severe cardiac disease: NYHA grade 3-4, CNS involvement at diagnosis, Uncontrolled serious infection, Impaired liver (transaminases > 3x normal upper limit or bilirubin > 1.5 x normal upper limit, unless due to Gilbert´s syndrome), renal (GFR<30ml/min) or other organ function not caused by lymphoma, which will interfere with the treatment, Absolute neutrophil count (ANC) <1000 cells/µL or platelets <100,000 cells/µL, unless due to lymphoma, Any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma, unless treated with curative intent, and without relapse since 2 years, or low grade prostate cancer, not in need of treatment, Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study, Known hypersensitivity to rituximab, polatuzumab vedotin, cyclophosphamide, vincristine or doxorubicin, or to additives in the formulations above, or known hypersensitivity to other human, humanized, chimeric or porcine monoclonal antibodies, or HACA against rituximab, Peripheral neuropathy grade = 2

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified