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Screen for hepatitis B virus in all cancer patients starting systemic treatment. Find out more about hepatitis B virus screening and management.

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.

ABFM(MNT); ABFM+NELA(MNT)

Cancer Type:
Hematologic, 
Leukemia - Acute Lymphoblastic (ALL)
Intent: Curative
Regimen Category: evidence-informed
Funding:
ODB - General Benefit
    prednisone
ODB - General Benefit
    methotrexate - oral tablets
ODB - General Benefit
    mercaptopurine
New Drug Funding Program
    Nelarabine - Newly Diagnosed T-cell Acute Lymphoblastic Leukemia
A - Regimen Name

ABFM+NELA(MNT) Regimen
Augmented Berlin-Frankfurt-Münster regimen (Maintenance) - Nelarabine
ABFM(MNT) Regimen
Augmented Berlin-Frankfurt-Münster regimen (Maintenance)


Disease Site
Hematologic
Leukemia - Acute Lymphoblastic (ALL)


Intent
Curative

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.

The information provided in this document is intended for use only in the management of adults with leukemia, and for cancer centres with expertise in treating acute leukemia.


Rationale and Uses

Treatment of adult patients (up to 30 years) with newly diagnosed intermediate- or high-risk T-cell acute lymphoblastic leukemia (T-ALL)


Supplementary Public Funding

prednisone
ODB - General Benefit (prednisone) (ODB Formulary )

methotrexate
ODB - General Benefit (methotrexate - oral tablets) (ODB Formulary )

mercaptopurine
ODB - General Benefit (mercaptopurine) (ODB Formulary )

nelarabine
New Drug Funding Program (Nelarabine - Newly Diagnosed T-cell Acute Lymphoblastic Leukemia) (NDFP Website )

 
B - Drug Regimen

Based on the AALL0434 protocol

Cycles 1 to 3:

methotrexate
15 mg IT Day 1
vinCRIStine
1.5 mg /m² IV Days 1, 57
(maximum 2 mg per dose)
prednisone
20 mg /m² PO BID on Days 1-5, 57-61
mercaptopurine

1

75 mg /m² PO Days 1-28, 36-84
methotrexate

1

20 mg /m² PO Days 8, 15, 22, 36, 43, 50, 57, 64, 71, 78
nelarabine
650 mg /m² IV Days 29-33


1 See protocol for dose escalation during maintenance.

Cycles 4 and onward:

methotrexate
15 mg IT Day 1
vinCRIStine
1.5 mg /m² IV Days 1, 29, 57

(maximum 2 mg per dose)

prednisone
20 mg /m² PO BID on Days 1-5, 29-33, 57-61
mercaptopurine

1

75 mg /m² PO Days 1 to 84
methotrexate

1

20 mg /m² PO Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78

1 See protocol for dose escalation during maintenance

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C - Cycle Frequency

ABFM+NELA(MNT) every 12 weeks x 3 cycles, then ABFM(MNT) every 12 weeks with duration based on sex as listed below.

For female patients, continue maintenance therapy until the total duration of therapy is 2 years from the start of Interim Maintenance [ABFM(INTERIM MNT)].

For male patients, continue maintenance therapy until the total duration of therapy is 3 years from the start of Interim Maintenance [ABFM(INTERIM MNT)].

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Minimal

Other Supportive Care:

  • Also refer to CCO Antiemetic Recommendations
  • Antiemetics should be given as per institutional guidelines.
  • Consider PJP and other prophylaxis for infection based on institutional guidelines.
 
J - Administrative Information

Pharmacy Workload (average time per visit)
ABFM+NELA(MNT)
17.604 minutes
ABFM(MNT)
17.604 minutes
Nursing Workload (average time per visit)
ABFM+NELA(MNT)
38.611 minutes
ABFM(MNT)
38.611 minutes
 
K - References

CADTH reimbursement recommendation: Nelarabine (for addition to front-line multiagent therapy of pediatric, adolescent, and young adult patients (aged 1 year to 30 years at
diagnosis) with intermediate- or high-risk T-cell acute lymphoblastic leukemia). October 2023.

Dunsmore KP, Winter SS, Devidas M, et al. Children's Oncology Group AALL0434: A phase III randomized clinical trial testing nelarabine in newly diagnosed T-cell acute lymphoblastic leukemia. J Clin Oncol. 2020 Oct 1;38(28):3282-93. doi: 10.1200/JCO.20.00256. 

May 2024 new ST-QBP regimen


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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.