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Trial registered on ANZCTR


Registration number
ACTRN12619000518167p
Ethics application status
Not yet submitted
Date submitted
22/01/2019
Date registered
1/04/2019
Date last updated
1/04/2019
Date data sharing statement initially provided
1/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A study of pembrolizumab following chemoimmunotherapy for primary central nervous system lymphoma
Scientific title
An ALLG Phase II study of pembrolizumab checkpoint blockade following chemoimmunotherapy for primary central nervous system lymphoma
Secondary ID [1] 297179 0
ALLG NHL32
Universal Trial Number (UTN)
Trial acronym
BLOCK PCNSL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary central nervous system lymphoma 311217 0
Condition category
Condition code
Cancer 309844 309844 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive an induction treatment of either a. Rituximab, Methotrexate, Procarbazine & Vincristine (R-MPV) Cytarabine (Ara-C) or b.Methotrexate, Cytarabine, Thiopeta & Rituximab (MATRix) Chemoimmunotherapy Induction Therapy (CIT) the induction treatment given is at the discretion of the participants clinician and is not assessed as part of this study.

Once the induction treatment is complete participants will receive Pembrolizumab 200mg IV commencing 4-6 weeks after last CIT exposure and administered once every 3 weeks for 35 cycles / 2 years. At each Pembrolizumab clinical visit, the participant will be advised of their following appointment.
Intervention code [1] 313438 0
Treatment: Drugs
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318798 0
Progression free survival. (The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse).
Timepoint [1] 318798 0
PFS will be measured at 1 year post commencement of pembrolizumab.
Primary outcome [2] 318799 0
Adverse events, SAE's and events of clinical interest. (This is a composite) These events will be assessed by checking hospital records/results and as reported by the patient.
Timepoint [2] 318799 0
Ongoing until 30 days after the last administration of study drug for each patient.
Secondary outcome [1] 366077 0
Progression free survival. (The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse).
Timepoint [1] 366077 0
2 years post commencement of pembrolizumab.
Secondary outcome [2] 366078 0
Overall survival.
Timepoint [2] 366078 0
2 years post commencement of pembrolizumab.

Eligibility
Key inclusion criteria
Treatment-naïve new diagnosis of PCNSL (DLBCL)
Age = greater than or equal to 18 years
ECOG = less than or equal to 3
Considered appropriate for induction CIT as per investigator
No standard contraindication to immune checkpoint inhibition
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active autoimmune disease
Unfit for induction CIT (prohibitive organ dysfunction)
Non-B-cell lymphoma subtype
Systemic involvement with aggressive lymphoma

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 21378 0
New Zealand
State/province [1] 21378 0

Funding & Sponsors
Funding source category [1] 301731 0
Commercial sector/Industry
Name [1] 301731 0
Merck, Sharp and Dohme
Address [1] 301731 0
Level 1 - Building A, 26 Talavera Road
Macquarie Park, NSW, 2113
North Ryde Post Business Centre
Locked Bag 2234
North Ryde, NSW, 1670
Australia
Country [1] 301731 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Leukaemia and Lymphoma Group
Address
ALLG
35 Elizabeth St
Richmond
Vic
3121
Country
Australia
Secondary sponsor category [1] 301472 0
None
Name [1] 301472 0
Address [1] 301472 0
Country [1] 301472 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 302456 0
The Monash Health Human Research Ethics Committee
Ethics committee address [1] 302456 0
Research Support Services
Level 2, i Block,
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168
Ethics committee country [1] 302456 0
Australia
Date submitted for ethics approval [1] 302456 0
01/08/2019
Approval date [1] 302456 0
Ethics approval number [1] 302456 0

Summary
Brief summary
The purpose of this study is to determine if a standard chemotherapy induction therapy followed by maintenance using pembrolizumab will be effective in maintaining life expectancy with minimal side effects for participants.

Who is it for?

You may be eligible for this study if you are an adult with has been diagnose with primary central nervous system lymphoma.

Study details

All participants in this study will complete a standard induction treatment followed by pembrolizumab, via a drip into the blood vessel, every 3 weeks for 2 years.
Throughout the study scans will be performed at various time points such as Magnetic Reasonance imaging (MRI) and Positron Emission Tomography (PET scans) to take pictures inside your body.
Blood samples will also be taken throughout the treatment period, however these are the same as you would have taken during standard treatment outside of the trial.


It is hoped that this treatment will result in a better prognosis for those with primary central nervous system lymphoma, with less severe side effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90282 0
Dr Gareth Gregory
Address 90282 0
Monash Medical Centre
Level 4, 246 Clayton Rd
Clayton
Vic 3168
Country 90282 0
Australia
Phone 90282 0
+61 3 9594 6666
Fax 90282 0
Email 90282 0
Gareth.gregory@monash.edu
Contact person for public queries
Name 90283 0
Ms Delaine Smith
Address 90283 0
ALLG
35 Elizabeth St
Richmond
Vic
3121
Country 90283 0
Australia
Phone 90283 0
+61 3 8373 9701
Fax 90283 0
Email 90283 0
delaine.smith@allg.org.au
Contact person for scientific queries
Name 90284 0
Ms Delaine Smith
Address 90284 0
ALLG
35 Elizabeth St
Richmond
Vic
3121
Country 90284 0
Australia
Phone 90284 0
+61 3 8373 9701
Fax 90284 0
Email 90284 0
delaine.smith@allg.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual patient data will not be shared publically. Aggregate patient data and final results will be presented in the final report
What supporting documents are/will be available?
No other documents available
Summary results
No Results