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RecruitingLast updated:24 July 2023

ALLG-PACIFIC: This study is evaluating whether combining immunotherapy with chemotherapy will improve outcomes for people with primary mediastinal B-cell lymphomaNHL35 -An Australasian Leukaemia and Lymphoma Group open label phase II study of the effect of of R-CHOP in combination with pembrolizumab in patients with newly diagnosed primary mediastinal B Cell Lymphoma (PMBL).

Clinical summary

Summary

This study is testing whether adding immunotherapy (called pembrolizumab) to R-CHOP chemotherapy (consisting of rituximab, cyclophosphamide, doxorubicin, vincristine, prednisolone) improves survival of patients with primary mediastinal B-cell lymphoma. All participants will receive the following treatment. All treatment cycles are 21 days. Cycles 1 and 2: R-pembro 'window': rituximab 375mg/m2 Intravenous infusion (IV) on Day 1 + pembrolizumab 200mg via IV on Day 1. Cycles 3-8 'Induction': rituximab 375mg/m2 via IV on Day 1, cyclophosphamide 750mg/m2 via IV on Day 1, doxorubicin 50mg/m2 via IV on Day 1, vincristine 1.4mg/m2 via IV on Day 1 capped at 2mg, prednisolone 100mg oral tablet on Days 1-5, and pembrolizumab 200mg via IV on Day 1. Cycles 9-17 pembrolizumab 'consolidation': pembrolizumab 200mg via IV on Day 1. Participants will have a PET/CT Scan at the following timepoints: after registration, after the 'pembro' phase, and after the 'induction' phase. Participants may have another PET/CT Scan at the discretion of their treating physician. Patients will also have blood samples taken every three weeks whilst receiving treatment.

Age

People18+

Phase

II

Trial Acronym

ALLG-PACIFIC

More information

Trial Identifiers

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Commercial Sponsor

Australasian Leukaemia and Lymphoma Group (ALLG)

Scientific Title

NHL35 -An Australasian Leukaemia and Lymphoma Group open label phase II study of the effect of of R-CHOP in combination with pembrolizumab in patients with newly diagnosed primary mediastinal B Cell Lymphoma (PMBL).

Eligibility

Inclusion

  • You have certain types of non-cancer medical conditions.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Exclusion

  • You are able to swallow medication by mouth.
  • You have been diagnosed with cancer, but have not received any treatment.
Message

Clinical trials have complex eligibility criteria.

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