Drug Formulary information is intended for use by healthcare professionals. It is not intended to be medical advice. Some of the information, including information about funding for cancer drugs, does not apply to all patients. Cancer treatment plans are unique to each patient. If you are a patient, please speak with your healthcare team to understand how this information applies to you.
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regimen-monograph
ACALVENE
Cancer Type
Hematologic,
Leukemia - Chronic Lymphocytic (CLL)
Intent
Palliative
Regimen Category
Evidence-informed
Drugs Used
QBP Type
Unfunded
This drug is not currently publicly funded for this regimen and intent
A - Regimen Name
ACALVENE Regimen
Acalabrutinib-Venetoclax
Disease Site
Hematologic
Leukemia - Chronic Lymphocytic (CLL)
Intent
Palliative
Regimen Category
Evidence-informed :
Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR). Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.
This Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Rationale and Uses
Therapy for previously untreated chronic lymphocytic leukemia
B - Drug Regimen
Cycles 1 to 2:
| acalabrutinib | 100 mg | PO | BID, Days 1-28 |
| (This drug is not currently publicly funded for this regimen and intent) | |||
|
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| acalabrutinib | 100 mg | PO | BID, Days 1-28 |
| (This drug is not currently publicly funded for this regimen and intent) | |||
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And Venetoclax Ramp-up: |
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| venetoclax | 20 mg | PO | Daily, Days 1-7 |
| (This drug is not currently publicly funded for this regimen and intent) | |||
| venetoclax | 50 mg | PO | Daily, Days 8-14 |
| (This drug is not currently publicly funded for this regimen and intent) | |||
| venetoclax | 100 mg | PO | Daily, Days 15-21 |
| (This drug is not currently publicly funded for this regimen and intent) | |||
| venetoclax | 200 mg | PO | Daily, Days 22-28 |
| (This drug is not currently publicly funded for this regimen and intent) | |||
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|
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| acalabrutinib | 100 mg | PO | BID, Days 1-28 |
| (This drug is not currently publicly funded for this regimen and intent) | |||
| venetoclax | 400 mg | PO | Daily; Days 1-28 |
| (This drug is not currently publicly funded for this regimen and intent) | |||
C - Cycle Frequency
REPEAT EVERY 28 DAYS
For 2 cycles of acalabrutinib AND 12 cycles of acalabrutinib and venetoclax (including venetoclax ramp-up period), unless disease progression or unacceptable toxicity
D - Premedication and Supportive Measures
Antiemetic Regimen:
Low – No routine prophylaxis; PRN recommended
- Also refer to CCO Antiemetic Recommendations.
Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.
Other Supportive Care:
Correct potassium, uric acid, phosphorus, calcium, and creatinine abnormalities prior to treatment initiation.
Consider prophylaxis for patients at an increased risk for opportunistic infections and prophylactic use of G-CSF according to local guidelines.
Prophylaxis for TLS (in CLL patients)
- Tumour lysis prophylaxis (i.e. adequate hydration and anti-hyperuricemic agents) prior to and during ramp-up phase is required for all patients.
- Prophylaxis based on tumour burden in table below.
Tumour Burden |
Prophylaxis |
Blood Chemistry Monitoringc,d |
||
Hydrationa |
Anti-hyperuricemicsb |
Setting and Frequency of Assessments |
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Low |
All LN < 5 cm AND ALC < 25 x 109/L |
Oral (1.5 to 2 L) |
Allopurinol |
Outpatient:
|
Medium |
Any LN 5 cm to < 10 cm OR ALC ≥ 25 x 109/L
|
Oral (1.5 to 2 L) and consider additional IV |
Allopurinol |
Outpatient:
|
High |
Any LN ≥ 10 cm OR ALC ≥ 25 x 109/L AND any LN ≥ 5 cm |
Oral (1.5 to 2 L) and IV (150 to 200 mL/hr, as tolerated) |
Allopurinol; consider rasburicase if elevated uric acid at baseline |
In hospital at first dose of 20 mg and 50 mg
Outpatient at subsequent ramp-up doses
|
ALC= absolute lymphocyte count; LN= lymph node
a. Start oral hydration 2 days before and continue during ramp-up. Administer IV hydration if unable to tolerate oral.
b. Start allopurinol or xanthine oxidase inhibitor for 2-3 days prior to starting venetoclax.
c. Evaluate blood chemistries (potassium, phosphorus, uric acid, calcium, creatinine); review in real time.
d. For patients at continued risk of TLS, monitor blood chemistries at 6 to 8 hours and at 24 hours at each subsequent ramp-up dose.
K - References
Acalabrutinib drug monograph. Ontario Health (Cancer Care Ontario).
Brown JR, Seymour JF, Jurczak W, et al. Fixed-duration acalabrutinib combinations in untreated chronic lymphocytic leukemia. N Engl J Med 2025 Feb 20;392(8):748-62. doi: 10.1056/NEJMoa2409804.
Reimbursement recommendation: acalabrutinib. Canada's Drug Agency, January 2026.
Venetoclax drug monograph. Ontario Health (Cancer Care Ontario).
June 2026 new ST-QBP regimen
M - Disclaimer
Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.
Last Updated: July 21, 2026
