R-MINI-CHOP versus R-MINI-CHP in combination with polatuzumab-vedotin, as primary treatment for patients with diffuse large B-cell lymphoma, >= 80 years, or frail >= 75 years – an open label randomized Nordic Lymphoma Group phase III trial.

Phase 1

Active, not 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) refractorySystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2018-003889-14-IT
• Lead Sponsor: Skane University Hospital, Department of Oncology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-02
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Age greater than or equal to 80 years or frail greater than or equal to 75 years, according to simplified comprehensive geriatric assessment
2. 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
3. Stage II-IV disease
4. At least 1 measurable site of disease (>1.5 cm long axis)
5. No previous treatment for lymphoma
6. WHO performance status 0 – 3 (Grade 3 if related to DLBCL)
7. Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

1. Severe cardiac disease: NYHA grade 3-4
2. CNS involvement at diagnosis
3. Uncontrolled serious infection
4. 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
5. Absolute neutrophil count (ANC) <1000 cells/¿L or platelets <100,000 cells/¿L, unless due to lymphoma
6. 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
7. Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study
8. 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
9. Peripheral neuropathy grade = 2

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to evaluate if progression-free survival with pola-R-mini-CHP is superior to that of R-mini-CHOP.;Secondary Objective: To compare response duration, complete remission rate (CR), overall<br>response rate (ORR), health-related quality of life (HRQOL), lymphoma<br>specific survival (LSS), overall survival (OS), and safety between these<br>regimens.;Primary end point(s): Progression-free survival:<br>This is defined as the interval between randomization date and date of documented progression, first relapse, or death of any cause. Otherwise, patients will be censored at the last date they were known to be alive.;Timepoint(s) of evaluation of this end point: Continuously during time from randomization, treatment phase, and follow up phase (36 month after end of treatment), so 5 years.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Overall survival:<br>This is defined as time from registration to death of any cause.;Timepoint(s) of evaluation of this end point: Continuously during time from randomization, treatment phase, and follow up phase (36 month after end of treatment), so 5 years.