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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 (POLAR BEAR)

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ClinicalTrials.gov Identifier: NCT04332822
Recruitment Status : Recruiting
First Posted : April 3, 2020
Last Update Posted : July 9, 2021
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Nordic Lymphoma Group

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
DLBCL Diffuse Large B Cell Lymphoma Drug: R-pola-mini-CHP Drug: R-mini-CHOP Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 19, 2020
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : February 28, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm A - R-mini-CHOP

Cycles 1-6, duration 21 days

  • Rituximab 375 mg/m2 i.v., day 1, cycle 1. 1400 mg s c OR 375 mg/m2 i. v. cycles 2-6
  • Cyclophosphamide 400 mg/m2 i.v., day 1, cycles 1-6
  • Doxorubicin 25 mg/m2 i.v., day 1, cycles 1-6
  • Vincristine 1 mg i.v. (total dose), day 1, cycles 1-6
  • Prednisone, 40 mg/m2 p.o, days 1-5, , cycles 1-6
 Drug: R-mini-CHOP
  • Rituximab 375 mg/m2 i.v., day 1, cycle 1. 1400 mg s c OR 375 mg/m2 i. v. cycles 2-6
  • Cyclophosphamide 400 mg/m2 i.v., day 1, cycles 1-6
  • Doxorubicin 25 mg/m2 i.v., day 1, cycles 1-6
  • Vincristine 1 mg i.v. (total dose), day 1, cycles 1-6
  • Prednisone, 40 mg/m2 p.o, days 1-5, , cycles 1-6
Experimental: Arm B - R-pola-mini-CHP

Cycles 1-6, duration 21 days

  • Rituximab 375 mg/m2 i.v., day 1, cycle 1. 1400 mg s c OR 375 mg/m2 i. v. cycles 2-6
  • Cyclophosphamide 400 mg/m2 i.v., day 1, cycles 1-6
  • Doxorubicin 25 mg/m2 i.v., day 1, cycles 1-6
  • Prednisone, 40 mg/m2 p.o, days 1-5, , cycles 1-6
  • Polatuzumab vedotin 1.8 mg/kg i.v day 1 cycles 1-6
 Drug: R-pola-mini-CHP
  • Rituximab 375 mg/m2 iv, day 1, cycle 1. 1400 mg s c OR 375 mg/m2 iv cycles 2-6
  • Cyclophosphamide 400 mg/m2 iv, day 1, cycles 1-6
  • Doxorubicin 25 mg/m2 iv , day 1, cycles 1-6
  • Prednisone, 40 mg/m2 po, days 1-5, cycles 1-6 - round up to nearest 25 mg
  • Polatuzumab vedotin 1.8 mg/kg iv day 1 cycles 1-6


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival (PFS). [ Time Frame: 2 years. ]
    The primary end point of this study is PFS. The null hypothesis is that pola-R-mini-CHP is equivalent to R-mini-CHOP. PFS is defined as the interval between registration date and date of documented progression or lack of response, first relapse, or death of any cause. Otherwise, patients will be censored at the last date they were known to be alive. For patients with PD as best response, PFS is defined as 1 day.


Eligibility Criteria
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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    1. diffuse large B-cell lymphoma, including transformation from an indolent lymphoma
    2. follicular lymphoma grade 3B
    3. T-cell/histiocyte-rich LBCL
    4. primary cutaneous DLBCL, leg type
    5. EBV-positive DLBCL, NOS
    6. primary mediastinal LBCL
    7. 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 HACA against rituximab
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04332822


Contacts
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Contact: Mats Jerkeman 0046704973507 mats.jerkeman@med.lu.se

Locations
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Sponsors and Collaborators
Nordic Lymphoma Group
Roche Pharma AG
Investigators
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Principal Investigator: Mats Jerkeman Department of Oncology, Skåne University Hospital
More Information
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Responsible Party: Nordic Lymphoma Group
ClinicalTrials.gov Identifier: NCT04332822    
Other Study ID Numbers: NLG-LBC7 POLAR BEAR
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: July 9, 2021
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nordic Lymphoma Group:
DLBCL
Diffuse Large B Cell Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin