HL35: A study of Pembrolizumab And Chemo-Immunotherapy as FIrst-line therapy for patients with primary mediastinal B-Cell lymphoma.

Phase 2

Recruiting

• Conditions: Primary mediastinal B-cell lymphoma; Cancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

• Registration Number: ACTRN12621001529831
• Lead Sponsor: Australasian Lymphoma and Leukaemia Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-10
• Last Update Posted: 10 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 35

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 chemotherapy, radiotherapy or other investigational drug.
5.Eastern Collaborative Oncology Group performance status 0-<=1.
6.Platelets >= 100x109/l; neutrophils >= 1.0x109/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%

Exclusion Criteria

1.Known hypersensitivity to any study medication, including previous grade >=3 hypersensitivity reactions to monoclonal antibody therapy.
2.Active autoimmune disease; requiring immunosuppressive therapy within 6 months of study entry.
3.Other lymphoma subtypes, other than PMBL.
4.Central nervous system, meningeal or spinal cord involvement by lymphoma.
5.Prior therapy with any antibody or drug targeting T-cell coregulatory proteins (immune checkpoints) such as PD-1, PD-L1, or cytotoxic T-lymphocyte antigen-4 (CTLA-4).
6.Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. – Please note that a short course of steroids (e.g. Oral Prednisolone 1mg/kg daily or equivalent for <=7 days duration) will be permitted if indicated for lymphoma symptoms (but should be avoided if possible)

Study & Design

• Study Type: Interventional
• Study Design: Not specified