Zanubrutinib Plus Rituximab (Zanu -R) as Fixed Duration, Early Intervention Versus Observation for Patients With Indolent Mantle Cell Lymphoma: a Randomised Phase II Clinical Trial

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Phase II, multicentre, randomised, open-label study to assess the benefit of early intervention with fixed duration, time-limited zanubrutinib-rituximab in indolent mantle cell lymphoma (MCL)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years of age or over.

• Life expectancy ≥ 6 months.

• Pathologically confirmed MCL, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1, D2 or D3.

• Stage II-IV MCL measurable by CT imaging or by white cell count (WCC)/BM infiltration.

• 'Indolent' MCL, defined as 1 or more of the following:

‣ Observation with no treatment for a minimum of 6 months after the initial diagnosis

⁃ Leukaemic non-nodal variant (lymphocytosis/splenomegaly only without nodal involvement)

⁃ Low tumour volume (largest lymph node ≤ 3cm in maximal diameter), proliferation fraction (Ki67 or equivalent) ≤30% and classical morphology (non-blastoid/pleomorphic)

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.

• Absolute neutrophil count ≥1.0 x 109/L and platelets ≥75 x 109/L independent of growth factor support.

• AST and/or ALT ≤3 x upper limit of normal (ULN).

• Total Bilirubin ≤1.5 x ULN unless due to Gilberts syndrome or of non-hepatic origin unless directly attributable to the patient's MCL.

⁃ Calculated creatinine clearance ≥30 mL/min. Glomerular filtration rate (GFR) ≥30 mL/min directly measured with 24 hour urine collection, or creatinine clearance calculated according to the modified formula of Cockcroft and Gault (for men: GFR ≈ ((140 - age) x bodyweight)/ (72 x creatinine), for women x 0, 85).

⁃ Able to give voluntary written informed consent.

⁃ Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.

⁃ Negative serum or urine pregnancy test for women of childbearing potential (WOCBP).

⁃ Willing to comply with the contraceptive requirements of the trial.

Locations
Other Locations
United Kingdom
Royal Derby Hospital
RECRUITING
Derby
Beatson West of Scotland Cancer Centre
RECRUITING
Glasgow
Clatterbridge Cancer Centre
RECRUITING
Liverpool
Guy's Hospital
RECRUITING
London
St Bartholomew's Hospital
RECRUITING
London
University College London Hospital
RECRUITING
London
Christie Hospital
RECRUITING
Manchester
Norfolk and Norwich University Hospitl
RECRUITING
Norwich
Nottingham City Hospital
RECRUITING
Nottingham
Churchill Hospital
RECRUITING
Oxford
Derriford Hospital
RECRUITING
Plymouth
Southampton General Hospital
RECRUITING
Southampton
Royal Cornwall Hospital
RECRUITING
Truro
Contact Information
Primary
ZEBRA Trial Manager
ctc.zebra@ucl.ac.uk
(+44) (0)2076799860
Time Frame
Start Date: 2024-05-17
Estimated Completion Date: 2028-10
Participants
Target number of participants: 50
Treatments
No_intervention: Arm A: Control
Active observation
Experimental: Arm B: Experimental
Time limited Zanubrutinib-R 6 x 28 day cycles
Sponsors
Collaborators: BeiGene
Leads: University College, London

This content was sourced from clinicaltrials.gov

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