Author picture

Mutated Cll on I+V

Patient info
Biological Sex: Female
Year of birth: 1960
Case details
Diagnosis: Chronic lymphocytic leukemia
Date of diagnosis:
July
2019
Type of current or last treatment: Venetoclax+Ibrutinib
Description of other type of current or last treatment: I+V
Doses of current or last treatment:
- Ibrutinib:480mg
- venetoclax:400mg
Date of current or last treatment: ​ November
2023
Doses of initiation treatment:
- Venetoclax:100mg
Date of initiation of current treatment: ​ July
2023
Is the treatment ongoing? Yes
Date of treatment interruption: ​ January
2023
Current or last line of treatment: 1
Karyotype result before current treatment: 46, XX
Concomitant medication(s): ondasetron TTS
Current adverse event: nausea, vomiting
Previous adverse events: none
Comorbidities: none
Grade of current adverse event: 2
Cycle of the adverse event initiation: 1
Days since the adverse event onset: 40
Before current treatment
IGHV gene status: Mutated
del17p: Negative
TP53 mutation status: Absent
Case description:

Patient complted 3 cycles on ibrutinib and venetoclax was introduced. She started complaining of nausea and vomiting. Uper GI endoscopy was negative. She was started on ondasetron with no improvement. Later she was started on akynzeo with lowering venetoclax to 200 mg x 1. We tried this strategy for 2 weeks and she reported mild improvement, but still her quality of life was affected. We then tried ondasetron TTS with 200 mg of venetoclax. The same. We stopped venetoclax for 5 days all symptoms resolved. We later reintroduced venetoclax at the dose of 100 mg along with ondasetron TTS. She remains on this schedule. If there is anything else you could suggest, I would really appreciate it. Please note that the patient’s weight is 50 kg and on the drop down menu of the dates 2024 is not an option. I have chosen 2023 but the CORRECT is 2024 – please consider adding year 2024 as an option. Many thanks in advance! EH

Case ID:
3038
Raised by:
Eleftheria Hatzimichael
Date & Time:
2024-11-30 13:31:17
Topic: Adverse events after initial drug administration
Author picture

Mutated Cll on I+V

Patient complted 3 cycles on ibrutinib and venetoclax was introduced. She started complaining of nausea and vomiting. Uper GI endoscopy was negative. She was started on ondasetron with no improvement. Later she was started on akynzeo with lowering venetoclax to 200 mg x 1. We tried this strategy for 2 weeks and she reported mild improvement, but still her quality of life was affected. We then tried ondasetron TTS with 200 mg of venetoclax. The same. We stopped venetoclax for 5 days all symptoms resolved. We later reintroduced venetoclax at the dose of 100 mg along with ondasetron TTS. She remains on this schedule. If there is anything else you could suggest, I would really appreciate it. Please note that the patient’s weight is 50 kg and on the drop down menu of the dates 2024 is not an option. I have chosen 2023 but the CORRECT is 2024 – please consider adding year 2024 as an option. Many thanks in advance! EH

Internal Board Messages
Yair Herishanu
1 year

In general, nausea and vomiting are common side effects of venetoclax and these symptoms are usually mild.
In case of nausea and vomiting, it is recommended to take venetoclax with food and plenty of water, frequent small meals instead of large ones and limiting consumption of fatty, fried, and spicy foods The most effective anti-nausea medication for severe nausea with venetoclax is Ondansetron.

In the present case, the patient has significant nausea and vomiting symptoms that impair his quality of life, despite good management of dose reduction and antiemetic therapy.

I would take one of the following approaches:
1 .Continue treatment with ibrutinib 420 mg/day and ventocalx 100 mg/day, and if possible after 12 months of I+V treatment, assess the depth of response with MRD testing in peripheral blood. Especially with positive MRD, I would consider extending the duration of treatment beyond 15 months (as in the original protocol). Given the CLL disease with good biomarkers (without del17p and mutated IGHV), the patient may benefit a prolonged remission even if the desired relative dose intensity of venetoclax was not achieved.
2. Stopping venetoclax and continuing with a BTK inhibitor (e.g. acalabrutinib) as continuous therapy

Write your opinion:
pedrotest2023
12 months

In general, nausea and vomiting are common side effects of venetoclax and these symptoms are usually mild.
In case of nausea and vomiting, it is recommended to take venetoclax with food and plenty of water, frequent small meals instead of large ones and limiting consumption of fatty, fried, and spicy foods The most effective anti-nausea medication for severe nausea with venetoclax is Ondansetron.

In the present case, the patient has significant nausea and vomiting symptoms that impair his quality of life, despite good management of dose reduction and antiemetic therapy.

I would take one of the following approaches:
1 .Continue treatment with ibrutinib 420 mg/day and ventocalx 100 mg/day, and if possible after 12 months of I+V treatment, assess the depth of response with MRD testing in peripheral blood. Especially with positive MRD, I would consider extending the duration of treatment beyond 15 months (as in the original protocol). Given the CLL disease with good biomarkers (without del17p and mutated IGHV), the patient may benefit a prolonged remission even if the desired relative dose intensity of venetoclax was not achieved.
2. Stopping venetoclax and continuing with a BTK inhibitor (e.g. acalabrutinib) as continuous therapy

Write your opinion:
Ticket ID:
3038
Raised by:
Date & Time:
2024-11-30 13:31:17
Subject: Adverse events after initial drug administration
Status: Published
Picture of Eleftheria Hatzimichael

Mutated Cll on I+V

Patient complted 3 cycles on ibrutinib and venetoclax was introduced. She started complaining of nausea and vomiting. Uper GI endoscopy was negative. She was started on ondasetron with no improvement. Later she was started on akynzeo with lowering venetoclax to 200 mg x 1. We tried this strategy for 2 weeks and she reported mild improvement, but still her quality of life was affected. We then tried ondasetron TTS with 200 mg of venetoclax. The same. We stopped venetoclax for 5 days all symptoms resolved. We later reintroduced venetoclax at the dose of 100 mg along with ondasetron TTS. She remains on this schedule. If there is anything else you could suggest, I would really appreciate it. Please note that the patient’s weight is 50 kg and on the drop down menu of the dates 2024 is not an option. I have chosen 2023 but the CORRECT is 2024 – please consider adding year 2024 as an option. Many thanks in advance! EH

Yair Herishanu
56 years
Ticket ID:
3038
Raised by:
Eleftheria Hatzimichael
Date & Time:
2024-11-30 13:31:17
Subject:
Adverse events after initial drug administration
Status:
Published