Venetoclax (in combination with rituximab) [VEN3]

The treatment of previously treated chronic lymphatic leukaemia

1. This application for venetoclax plus rituximab is being made by and the first cycle of this systemic anti -cancer therapy will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. The patient has been diagnosed with chronic lymphatic leukaemia or small lymphocytic lymphoma.
3. The patient has been tested for 17p deletion. Please indicate the result of this test below:

• Negative for 17p deletion or
• Positive for 17p deletion

4. The patient has been tested for TP53 mutation or has not been tested for TP53 mutation. Please indicate the result of this test below:

• Negative for TP53 mutation or
• Positive for TP53 mutation or
• TP53 mutation status not tested

5. The patient has symptomatic disease which requires systemic therapy.
6. The patient has been previously treated with systemic therapy for CLL/SLL. Please indicate the previous treatment that the patient has received:

• anti-CD20-containing chemoimmunotherapy alone
• a B cell receptor pathway inhibitor alone
• both anti-CD20-containing chemoimmunotherapy and a B cell receptor pathway inhibitor
• previous treatment with a venetoclax-containing combination with obinutuzumab/rituximab with or without other previous systemic therapies as well. Note: the patient must not have had progressive disease during venetoclax and obinutuzumab/rituximab
• previous treatment with ibrutinib plus venetoclax during which the patient did not have progressive disease
• several of the above

7. The previous treatment status as to whether the patient has or has not received a B cell receptor pathway inhibitor or inhibitors. Please indicate previous treatment below:

• previous treatment with a Bruton’s TKI (e.g. ibrutinib, acalabrutinib)
• previous treatment with a PI3Ki (e.g. idelalisib)
• previous treatment with both a BTKI and a PI3Ki
• no previous treatment with a BTKI or a PI3Ki

8. The number of previous lines of therapy that the patient has received:

• 1 previous line of treatment or
• 2 previous lines of treatment or
• 3 previous lines of treatment or
• 4 or more lines of previous treatment

9. The patient has a performance status of 0 or 1 or 2.
10. The patient has either not previously received venetoclax whether as monotherapy or in combination with obinutuzumab/rituximab or has been previously treated with venetoclax in combination with obinutuzumab/rituximab or the combination of ibrutinib plus venetoclax in which case the patient must not have progressed during such treatment with venetoclax. Please indicate previous treatment below:

• no previous treatment with venetoclax whether as monotherapy or in combination with obinutuzumab/rituximab
• previous treatment with venetoclax plus obinutuzumab during which the patient did not have progressive disease
• previous treatment with venetoclax plus rituximab during which the patient did not have progressive disease
• previous treatment with the combination of ibrutinib plus venetoclax during which the patient did not have progressive disease

11. Venetoclax will be given in combination with rituximab and that the rituximab will only be commenced after the patient has completed the venetoclax dose titration schedule.
12. All of the following for the prevention and treatment of tumour lysis syndrome:

• that the patient has been prospectively assessed for the risk of the development of tumour lysis syndrome (TLS) with venetoclax
• that appropriate TLS risk mitigation strategies have been put in place as outlined in the updated venetoclax Summary of Product Characteristics
• that there is a robust system in place for measuring appropriate blood chemistries both at the specified timings of blood chemistries according to TLS risk status and at the venetoclax dose levels described in Section 4.2 Table 3 of the Summary of Product Characteristics. See https://www.medicines.org.uk/emc/medicine/32650 or https://products.mhra.gov.uk/substance/?substance=VENETOCLAX
• that there is a robust system in place for ensuring the rapid review in real time of these blood chemistry results by a senior clinician with experience in the management of TLS
• that there is a robust system in place for the withholding of the next days dose of each scheduled dose escalation until the blood chemistry results have been confirmed as being satisfactory by a senior clinician

13. The patient has been assessed specifically for potential drug interactions with venetoclax.
14. The maximum treatment duration of venetoclax in this indication is for a maximum of 2 years (as measured from cycle 1 day 1 of rituximab administration)
15. The maximum treatment duration of rituximab will be for 6 cycles of rituximab
16. Venetoclax is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment or for the maximum treatment duration of 2 years (as measured from the cycle 1 day 1 administration of rituximab), whichever of these events is the sooner.
17. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, a treatment break approval form will be completed to restart treatment.
18. Venetoclax will be otherwise used as set out in its Summary of Product Characteristics.

NHS funded From: 28 May 2019

Additional information

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA561 (27 February 2019)

Current Form Version

Note

The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.

If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.