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Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
06/09/2019
Funder:
MSD
Sponsor:
UCL
Chief Investigator:
Dr Jaimal Kothari
Recruitment target:
42
EudraCT number:
2018-001767-23
Contact details:
ctc.PembroWM@ucl.ac.uk
Lay summary:
PembroWM
A phase II trial to investigate the safety and efficacy of rituximab and pembrolizumab in relapsed/refractory Waldenström’s macroglobulinaemia
Description
Design: A phase II, non-randomised, single arm, open-label trial.
Treatment: Pembrolizumab and rituximab given in 3 weekly cycles for a total of 18 cycles.  Pembrolizumab is given every cycle, rituximab is given a total of 8 times in the trial.
Key inclusion/exclusion criteria: Inclusion

Relapsed or refractory WM who have received ≥1 prior lines of therapy

Presenceof measurable disease (defined as a serum IgM level of >0.5 g/L)

ECOG performance status 0-2

Adequaterenal, liver, and bone marrow function

Exclusion

Refractory to rituximab

Clinically significant cardiac disease within 6months prior to registration

History of significant cerebrovascular disease inlast 6 months

Known central nervous system involvementof WM / Lymphoplasmacytic Lymphoma (LPL)

Prior history of haemolyticanaemia (either warm or cold)

History of colitis or pneumonitis

Received a T cell depletingantibody (e.g. alemtuzumab) within 3 months prior to starting treatment

Prior therapy with an anti-PD-1,anti-PD-L1or CTLA4 monoclonal antibody

Prior allogeneic bone marrowtransplantation

Known orsuspected hypersensitivity to components of pembrolizumab and/or rituximab (orother CD20 monoclonal antibody)

Duration of recruitment: 18 months
Aim
This trial aims to determine the safety, tolerability and efficacy of pembrolizumab in combination with rituximab in relapsed and refractory Waldenström’s macroglobulinaemia patients.
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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