A Randomized Multicenter Phase III Trial Comparing Treatment With R-mini-CHOP With R-mini-CHP + Polatuzumab Vedotin in Patients With Diffuse Large Cell B Cell Lymphoma

  • STATUS
    Recruiting
  • End date
    Feb 28, 2026
  • participants needed
    200
  • sponsor
    Nordic Lymphoma Group
Updated on 27 January 2021
vincristine
follicular lymphoma
b-cell lymphoma
high grade b-cell lymphoma
indolent lymphoma

Summary

This is a phase III, randomized, open-label, multicenter trial, conducted in Sweden, Norway, Finland, Denmark, Italy and Switzerland, in elderly patients with untreated diffuse large B-cell lymphoma. Elderly is defined as either 80 years of age, or 75 years and frail, according to a simplified Comprehensive Geriatric Assessment. Patients will be randomized 1:1 to either the standard treatment for this population, R-miniCHOP, or an experimental regimen, R-pola-miniCHP, where vincristine is substituted by an immunoconjugate, polatuzumab vedotin. The duration of the screening period is up to 4 weeks. The duration of active treatment is 18 weeks in both arms, and patients will be followed up to 36 months after end of treatment. Start of enrollment is planned in Q1 2020, and the last visit of the last patient included (end of trial) is estimated in Q1 2026.

Details
Condition Diffuse Large B-Cell Lymphoma, diffuse large cell lymphoma, diffuse large b cell lymphoma
Treatment R-pola-mini-CHP, R-mini-CHOP
Clinical Study IdentifierNCT04332822
SponsorNordic Lymphoma Group
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 75 yrs?
Gender: Male or Female
Do you have Diffuse Large B-Cell Lymphoma?
Do you have any of these conditions: diffuse large b cell lymphoma or Diffuse Large B-Cell Lymphoma or diffuse large cell lymphoma?
Do you have any of these conditions: Diffuse Large B-Cell Lymphoma or diffuse large cell lymphoma or diffuse large b cell lymphoma?
Do you have any of these conditions: diffuse large b cell lymphoma or Diffuse Large B-Cell Lymphoma or diffuse large cell lymphoma?
Age 80 years or frail 75 years, according to simplified comprehensive geriatric assessment
Histologically confirmed lymphoma belonging to one of the following subtypes
diffuse large B-cell lymphoma, including transformation from an indolent lymphoma
follicular lymphoma grade 3B
T-cell/histiocyte-rich LBCL
primary cutaneous DLBCL, leg type
EBV-positive DLBCL, NOS
primary mediastinal LBCL
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 Gilberts 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/L or platelets <100,000 cells/L, 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 HACA against rituximab
Clear my responses

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