Acalabrutinib in combination bendamustine and rituximab [ACA4]

Acalabrutinib in combination with bendamustine and rituximab for UNTREATED mantle cell lymphoma when an autologous stem cell transplant is UNSUITABLE where the following criteria have been met:

1. This application is both being made by, and the first cycle of systemic anti-cancer therapy will be prescribed by, a consultant or internally accredited haematology specialty trainee, specifically trained and assessed in the use of systemic anti-cancer therapy.
2. The patient has newly-diagnosed mantle cell lymphoma (MCL).
3. The patient has not received any prior systemic anti-cancer therapy for MCL.
4. The patient is ineligible for an autologous stem cell transplant.
5. The patient’s ECOG performance status is 0 or 1 or 2.
6. Acalabrutinib will only be administered in combination with bendamustine and rituximab in accordance with the following regimen, and will not be used in combination with any other agents outside this protocol: • Acalabrutinib: Administered continuously starting from Day 1 of Cycle 1 (each cycle is 28 days) until disease progression or unacceptable toxicity. 2 • Bendamustine: Administered at 90mg/m on Days 1 and 2 of each cycle for a total of 6 cycles. • Rituximab: Administered on Day 1 of each cycle for a total of 6 cycles. • Maintenance Rituximab: For patients achieving a response (partial response [PR] or complete response [CR]) after the initial 6 cycles, maintenance rituximab may be administered on Day 1 of every other cycle starting on Cycle 8 up to Cycle 30 (for a maximum of 12 additional doses).
7. When a treatment break of more than 6 weeks beyond the expected cycle length is needed, I will complete a treatment break approval form to restart treatment, which MUST be approved before treatment is re-commenced.
8. Acalabrutinib, bendamustine and rituximab will be otherwise be used as set out in their respective Summary of Product Characteristics.

CDF funded From: 06 August 2026

Additional information

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