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Trial registered on ANZCTR
Registration number
ACTRN12621001529831
Ethics application status
Approved
Date submitted
20/06/2021
Date registered
10/11/2021
Date last updated
31/05/2024
Date data sharing statement initially provided
10/11/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
NHL35: A study of Pembrolizumab And Chemo-Immunotherapy as FIrst-line therapy for patients with primary mediastinal B-Cell lymphoma.
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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).
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Secondary ID [1]3045380
None
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Universal Trial Number (UTN)
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Trial acronym
PACIFIC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Primary mediastinal B-cell lymphoma 3224100
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Condition category
Condition code
Cancer32006832006800
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The trial is a Phase II trial. Patients will receive the following treatment Cycle 1 and 2: R-pembro ‘window’ (21-day cycle) Cycle 3- to 8: ‘Induction’ (21-day cycle) - Cycle 9-17: Pembrolizumab ‘Consolidation’ (21-day cycle) Upon completion of the cycle, the next cycle will commence.
* Rituximab 375mg/m2 Intravenous Infusion on Day 1
* Pembrolizumab 200mg Intravenous Infusion on Day 1
* Rituximab 375mg/m2 Intravenous Infusion on Day 1
* Cyclophosphamide 750mg/m2 Intravenous Infusion on Day 1
* Doxorubicin 50mg/m2 Intravenous Infusion on Day 1
* Vincristine 1.4mg/m2 Intravenous Infusion on Day 1 capped at 2mg
* Prednisolone 100mg oral tablet on Day 1 to Day 5
* Pembrolizumab 200mg Intravenous Infusion on Day 1
* Pembrolizumab 200mg Intravenous Infusion on D1
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Intervention code [1]3208890
Treatment: Drugs
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Comparator / control treatment
No control
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]3279410
Percentage of patients achieving Event Free Survival . Event Free Survival will be assessed by medical reports and assessments of patients response.
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Timepoint [1]3279410
Measured from first dose of treatment to completion of treatment at 18 months
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Secondary outcome [1]3970610
To evaluate the safety by assessing the number of side effects seen per category of the Common Terminology Criteria for Adverse Events V5. Side effects will be assessed during the patient's regular clinic visit with the treating clinician and blood and urine biochemistry tests.
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Timepoint [1]3970610
Measured from date of registration to 30 days after administration of the last study treatment.
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Eligibility
Key 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 co*ckcroft 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%
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Minimum age
18Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealmentprocedures)
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Methods used to generate the sequence in which subjects will be randomised (sequencegeneration)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/12/2023
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Actual
13/01/2023
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Date of last participant enrolment
Anticipated
31/05/2025
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Actual
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Date of last data collection
Anticipated
31/05/2028
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Actual
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Sample size
Target
35
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Accrual to date
17
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,WA,VIC
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Recruitment hospital [1]266230
Sir Charles Gairdner Hospital - Nedlands
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Recruitment hospital [2]266240
Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [3]266250
Westmead Hospital - Westmead
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Recruitment hospital [4]266260
Liverpool Hospital - Liverpool
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Recruitment hospital [5]266270
Box Hill Hospital - Box Hill
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Recruitment hospital [6]266280
The Royal Adelaide Hospital - Adelaide
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Recruitment hospital [7]266290
Flinders Medical Centre - Bedford Park
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Recruitment hospital [8]266300
Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [9]266310
Gold Coast University Hospital - Southport
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Recruitment postcode(s) [1]426640
2050 - Camperdown
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Recruitment postcode(s) [2]426650
2145 - Westmead
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Recruitment postcode(s) [3]426660
2170 - Liverpool
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Recruitment postcode(s) [4]426700
3000 - Melbourne
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Recruitment postcode(s) [5]426670
3128 - Box Hill
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Recruitment postcode(s) [6]426710
4215 - Southport
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Recruitment postcode(s) [7]426680
5000 - Adelaide
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Recruitment postcode(s) [8]426690
5042 - Bedford Park
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Recruitment postcode(s) [9]426630
6009 - Nedlands
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Recruitment outside Australia
Country [1]237960
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State/province [1]237960
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Funding & Sponsors
Funding source category [1]3089040
Other Collaborative groups
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Name [1]3089040
Australasian Leukaemia and Lymphoma Group
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Country [1]3089040
Australia
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Primary sponsor type
Other Collaborative groups
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Name
Australasian Lymphoma and Leukaemia Group
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Address
ALLG
35 Elizabeth Street
Richmond Vic
3121
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Country
Australia
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Secondary sponsor category [1]3098270
None
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Name [1]3098270
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Address [1]3098270
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Country [1]3098270
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]3088030
Sir Charles Gairdner Human Research Ethics Committee
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Ethics committee address [1]3088030
Sir Charles Gairdner Hospital
Level 2, A Block, QEII Medical Centre
Hospital Avenue
Nedlands WA 6009
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Ethics committee country [1]3088030
Australia
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Date submitted for ethics approval [1]3088030
31/01/2022
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Approval date [1]3088030
29/07/2022
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Ethics approval number [1]3088030
RGS0000005286
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Summary
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. All patients will receive the following treatment regimen: Cycle 1-2: R-pembro ‘window’ (21-day cycle) Cycle 3-8: ‘Induction’ (21-day cycle) Cycle 9-17: Pembrolizumab ‘Consolidation’ (21-day cycle) Patients will have a PET/CT Scan at the following timepoints Patients will also have blood samples taken every three weeks whilst receiving treatment. It is hoped that this study may demonstrate that addition of pembrolizumab to R-CHOP may improve survival in patients with PMBL.
* rituximab 375mg/m2 Intravenous Infusion on Day 1
* pembrolizumab 200mg Intravenous Infusion on Day 1
* rituximab 375mg/m2 Intravenous Infusion on Day 1
* cyclophosphamide 750mg/m2 Intravenous Infusion on Day 1
*doxorubicin 50mg/m2 Intravenous Infusion on Day 1
*vincristine 1.4mg/m2 Intravenous Infusion on Day 1 capped at 2mg
*prednisolone 100mg oral tablet on Days 1-5
pembrolizumab 200mg Intravenous Infusion on D1
* pembrolizumab 200mg Intravenous Infusion on Day1
1. After Registration
2. After the "Pembro" phase
3. After the "Induction" phase
4. Patients may have another PET/CT scan at the discretion of their treating physician.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name1119420
Prof Chan Cheah
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Address1119420
Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands, WA, 6009
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Country1119420
Australia
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Phone1119420
+61383739701
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Fax1119420
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Email1119420
[emailprotected]
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Contact person for public queries
Name1119430
Ms Delaine Smith
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Address1119430
Australasian Leukaemia and Lymphoma Group
35 Elizabeth Street
Richmond
Vic
3121
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Country1119430
Australia
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Phone1119430
+61383739701
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Fax1119430
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Email1119430
[emailprotected]
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Contact person for scientific queries
Name1119440
Ms Delaine Smith
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Address1119440
Australasian Leukaemia and Lymphoma Group
35 Elizabeth Street
Richmond
Vic
3121
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Country1119440
Australia
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Phone1119440
+61383739701
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Fax1119440
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Email1119440
[emailprotected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Individual patient data will not be shared publicly. Aggregate patient data and final results will be presented in the final report
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
