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 (ZEBRA)

Research summary

Mantle cell lymphoma (MC) is an uncommon type of non-Hodgkins lymphoma. Most patients with MCL need to stat treatment soon after diagnosis,usually with a combination of chemotherapy and a 'targeted' treatment called rituximab. 25-30% of patients have 'indolent' (non-aggressive) MCL where the standard approach is an initial period of 'watchful waiting' followed by treatment with rituximab and chemotherapy when the lymphoma worsens (progresses). In this trial we will investigate whether there is a benefit of giving earlier treatment with zanubrutinib and rituximab (Zanu-R) compared to patients not being treated (watchful waiting). Patients who receive trial treatment will take zanubrutinib capsules twice a day,every day for up to six 28 day cycles and rituximab given as an infusion into a vein or around the first day of each cycle. Patients who do not receive trial treatment will continue active observation (watchful waiting) until clinical progression. All patients will be followed up for a minimum of 2 years following being enrolled into the trial until the last patient entering the trial completes their 2 year follow up visit. The trial will be conducted at NHS hospitals and is expected to last 4 years 6 months.

Principal Investigator

Dr Danmei Xu

Contact us

Email: Latephasehaematology@ouh.nhs.uk

IRAS number

1004772