Acalabrutinib in combination with venetoclax [ACA5]

Acalabrutinib in combination with venetoclax for the 1st line treatment of previously untreated chronic lymphocytic leukaemia 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 chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).
3. This patient has not received any prior systemic anti-cancer therapy for CLL/SLL.
4. The results of 17p deletion and TP53 mutation testing if known:

• Negative for 17p deletion and negative for TP53 mutation (Non-high-risk)
• Positive for 17p deletion and negative for TP53 mutation
• Negative for 17p deletion and positive for TP53 mutation
• Positive for 17p deletion and positive for TP53 mutation (High-risk)

5. The results of IGHV mutation testing if known:

• IGHV mutated
• IGHV unmutated
• IGHV testing result not known or not done

6. The patient has ECOG performance status 0, 1 or 2.
7. Patients who have started first line ibrutinib + venetoclax (TA891) may switch over to acalabrutinib if ibrutinib has been permanently discontinued solely due to severe, dose- limiting, or unacceptable toxicity. If there has been disease progression this switch is not permitted. The prescribing clinician confirms the following:

• Patient is starting acalabrutinib de novo and has not switched from first line ibrutinib (TA891). or
• Patient is switching from first line ibrutinib (TA891) to acalabrutinib due only to toxicity. There is no evidence of disease progression.

8. Acalabrutinib will only be given in combination with venetoclax and will not be used in combination with any other agents outside this regimen.
9. The maximum planned treatment duration of acalabrutinib is 14 x 4-weekly cycles and the maximum planned treatment duration of venetoclax is 12 x 4-weekly cycles.
10. Acalabrutinib plus venetoclax will be continued until disease progression, unacceptable toxicity, patient choice to stop, or reaching the maximum specified fixed duration (14 cycles of acalabrutinib / 12 cycles of venetoclax).
11. 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.
12. Acalabrutinib and venetoclax 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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The data on this page was produced using version 1.406 of the CDF list, downloaded from NHS England’s website on 12 August 2026 at 09:00.

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