The Feasibility and Clinical Efficacy of Atezolizumab Consolidation Treatment in High Risk (IPI > 2) DLBCL

Sponsor
Stichting Hemato-Oncologie voor Volwassenen Nederland
Study ID
NCT03463057
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Intervention Atezolizumab starts after 6 - 8 R-CHOP induction cycles (Rituximab, Cyclophosphamide, Hydroxo-doxorubicin, Vincristine and Prednisone (R-CHOP)); 18 cycles Atezolizumab followed by 12 months of observation

Study Details

The prognosis of Diffuse Large B cell Lymphoma (DLBCL) patients with an early relapse is dismal. Atezolizumab has shown promising activity in relapsed DLBCL patients. Toxicity data on atezolizumab are available for \> 6000 patients and is manageable. The assumption of this study is that atezolizumab consolidation will result in higher disease free survival by eradicating minimal residual disease In melanoma and lung cancer consolidation immunotherapy after chemoradiotherapy has shown an increase in survival.

Key Dates

Start date
Aug 30, 2018
Status verified
Oct 2025
Primary completion
Jan 18, 2024
Completion
Jan 31, 2027

Study Design

Enrollment
109 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Atezolizumab
    18 cycles atezolizumab followed by 12 months of observation

Primary Outcome Measure

Disease free survival (DFS) measured from the date of registration to relapse or death from any cause whichever comes first. [ Time Frame: 2 year after inclusion last patient ]

Related Studies