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RecruitingLast updated: 15 February 2024

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.

Conditions

This trial is treating patients with primary mediastinal B-Cell lymphoma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

II

Trial Acronym

ALLG-PACIFIC

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial 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

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

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)

Inclusion

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

Exclusion

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

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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