Description:
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.
Title
- Brief Title: 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
- 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
Clinical Trial IDs
- ORG STUDY ID:
NLG-LBC7 POLAR BEAR
- NCT ID:
NCT04332822
Conditions
- DLBCL
- Diffuse Large B Cell Lymphoma
Interventions
| Drug | Synonyms | Arms |
|---|
| R-pola-mini-CHP | | Arm B - R-pola-mini-CHP |
| R-mini-CHOP | | Arm A - R-mini-CHOP |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Arm A - R-mini-CHOP | Active Comparator | 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 | |
| Arm B - R-pola-mini-CHP | Experimental | 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 | |
Eligibility 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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 75 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Progression-free survival (PFS). |
| Time Frame: | 2 years. |
| Safety Issue: | |
| Description: | 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. |
Details
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Nordic Lymphoma Group |
Trial Keywords
- DLBCL
- Diffuse Large B Cell Lymphoma
Last Updated
July 9, 2021
