Status:
RECRUITING
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
Lead Sponsor:
Nordic Lymphoma Group
Collaborating Sponsors:
Roche Pharma AG
Conditions:
DLBCL
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
75+ years
Phase:
PHASE3
Brief Summary
This is a phase III, randomized, open-label, multicenter trial, conducted in Sweden, Norway, Finland, Denmark, Italy, Australia and New Zealand, in elderly patients with untreated diffuse large B-cell...
Eligibility Criteria
Inclusion
- 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
- 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 HACA against rituximab
- Peripheral neuropathy grade ≥ 2
Key Trial Info
Start Date :
August 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 28 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04332822
Start Date
August 19 2020
End Date
December 28 2028
Last Update
September 19 2024
Active Locations (69)
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1
Border Medical Oncology Research Unit
Albury, Australia
2
Royal Prince Alfred Hospital
Camperdown, Australia
3
Coffs Harbour
Coffs Harbour, Australia
4
Concord Repatriation General Hospital
Concord, Australia