CARAMEL
Research type
Research Study
Full title
Phase II Study of Acalabrutinib and Rituximab for Elderly or Frail Patients with Previously Untreated Mantle Cell Lymphoma
IRAS ID
1004530
Contact name
Nick McNally
Contact email
Sponsor organisation
University College London
Eudract number
2021-002393-42
Clinicaltrials.gov Identifier
Research summary
This study will test a combination of two drugs (acalabrutinib and rituximab) for elderly or frail patients with a type of non-Hodgkin lymphoma (NHL) called Mantle cell lymphoma (MCL). MCL accounts for 5-6% of NHL cases, and around one in three cases occur in patients aged 75 or older. Patients who are aged 80 or older live on average for less than 2 years after diagnosis. For younger patients and those without other health problems rituximab with chemotherapy, and sometimes stem cell transplantation, is the standard treatment, but for patients who are too frail for chemotherapy effective treatment options are limited.
Patients in this trial will have previously untreated MCL, will be aged 60 or older, and will be considered not fit enough to be treated with standard rituximab and chemotherapy combination treatment according to the trial eligibility criteria. Acalabrutinib belongs to the family of tablet cancer treatments called Bruton’s tyrosine kinase inhibitors (BTKis). Other BTKis are well-established as effective and well-tolerated treatments for patients with MCL that has relapsed after previous treatment but are not yet routinely used for first-line treatment. Rituximab is widely used already for many types of NHL including MCL. All patients in the trial will receive the same treatment. This will include acalabrutinib tablets taken twice a day and rituximab given on the first day of a 28-day cycle. This will be repeated 6 times. After 6
cycles of rituximab with acalabrutinib patients will continue to take daily acalabrutinib until their lymphoma comes back, or until they need to stop because of side-effects. The study will aim to assess whether acalabrutinib with rituximab given according to this protocol is an effective and well-tolerated treatment for elderly or frail patients with MCL who are not well enough to be treated with standard rituximab and chemotherapy combinations.REC name
South West - Central Bristol Research Ethics Committee
REC reference
23/SW/0009
Date of REC Opinion
22 Aug 2023
REC opinion
Further Information Favourable Opinion