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).

ACTRN 12621001529831

Brief Summary

This trial is for patients with primary mediastinal B-cell lymphoma (PMBL) and is evaluating if combining pembrolizumab with R-CHOP (Rituximab, cyclophosphamide, doxorubicin, vincristine, prednisolone) will improve patient outcomes.

Intervention/Treatment

• Drug: Rituximab
• Drug: Pembrolizumab
• Drug: Cyclophosphamide
• Drug: Doxorubicin
• Drug: Vincristine
• Drug: Prednisolone

Inclusion Criteria

1. Subjects aged equal to greater than 18 years at time of enrolment.
2. Able to give informed consent.
3. Clinical and histological diagnosis of PMBL, according to the current World Health Organization classification.
4. No previous treatment for lymphoma including chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells, radiotherapy or other investigational drug.
5. Eastern Collaborative Oncology Group performance status 0-<=1.
6. Platelets >= 100×109/l; neutrophilsa type of white blood cell that act as a first responder to infections in the body >= 1.0×109/l at the time of study entry.
7. Creatinine clearance >=30ml/min (calculated according to MRDR or Cockcroft Gault equation).
8. Total bilirubin less than or equal to 1.5 × ULN, AST and ALT less or equal to 2..5 x ULN.
9. LVEF greater or equal to 45%.