At a glance
ClinicalIndex Comparison Record- ✓Age ≥80 years or frail ≥75 years
- ✓Histologically confirmed DLBCL or related subtypes including transformation, follicular 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
- ✕Severe cardiac disease NYHA grade 3-4
- ✕CNS involvement at diagnosis
- ✕Uncontrolled serious infection
- ✕Impaired liver function: transaminases >3x upper limit normal or bilirubin >1.5x upper limit unless due to Gilbert syndrome
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT04332822Phase 3RecruitingUpdate OverdueUpdated 21mo ago · Completion was 6mo agoR-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
In Brief
A Phase 3 clinical trial evaluating R-pola-mini-CHP and R-mini-CHOP for DLBCL and Diffuse Large B Cell Lymphoma. Currently recruiting, targeting 300 participants across 69 sites in 7 countries.
Signals
Detailed 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 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 2027.
Study Details
Timeline
Interventions
* 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
* 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