Atezolizumab, Rituximab, Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory DLBCL Not Suitable for High-dose Therapy

Sponsor
University Hospital Southampton NHS Foundation Trust
Study ID
NCT03422523
Phase
PHASE2
Status
Terminated

Conditions

  • Diffuse Large B Cell Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma
  • Relapsed Diffuse Large B-Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Intravenous drip
  • Rituximab — DRUG
    Intravenous drip/or Subcutaneous from cycle 2
  • Gemcitabine 1000 mg — DRUG
    intravenous drip
  • Oxaliplatin 100 MG — DRUG
    intravenous drip

Study Details

This study evaluates the addition of Atezolizumab to current therapy of Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) for patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) that are not candidates for high-dose therapy. All patients will receive one cycle of R-GemOx. Three quarters of patients (Arm B) will go on to have a further 5 cycles (every 14 days) of R-GemOx with Atezolizumab, with one quarter of patients (Arm A) continuing with 5 cycles of R-GemOx. The patients in Arm B will continue to have Atezolizumab every 21 days for 8 cycles whilst Arm A patients will enter an observational phase during this time. Follow up will begin at 12 months from initial treatment until month 32.

Key Dates

Start date
May 9, 2018
Status verified
Aug 2022
Primary completion
Jan 31, 2021
Completion
Nov 18, 2021

Study Design

Enrollment
53 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A Control
    6 Cycles of R-GemOx (Rituximab, Gemcitabine and Oxaliplatin) every 14 days.
  • Experimental: Arm B Experimental
    1 Cycle of R-GemOx (Rituximab, Gemcitabine and Oxaliplatin) followed by 5 cycles of R-GemOx with Atezolizumab every 14 days. Followed by 8 maintenance cycles of Atezolizumab every 21 days.

Primary Outcome Measure

Progression free survival [ Time Frame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, up to follow up at month 36. ]

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