regimen-monograph

ALEM

Intent

Palliative

Regimen Category

Local

Drugs Used

alemtuzumab

A - Regimen Name

ALEM Regimen

Alemtuzumab

(Previously untreated)

Disease Site

Hematologic - Leukemia - Chronic Lymphocytic (CLL)

Intent

Palliative

Regimen Category

Local : A regimen not widely used by Regional Cancer Centres in this disease site.

Rationale and Uses

For treatment of patients with previously untreated progressive B-cell chronic lymphocytic leukemia

B - Drug Regimen

alemtuzumab

Administration and Escalation^a

Step		Dose	Next Steps
1^b	Initial dose / restart after ≥ 7 days hold	3mg Daily as a 2-hour IV infusion	When infusion toxicity ≤ G2, then proceed to step #2
2^b		10mg Daily as a 2-hour IV infusion	When infusion toxicity ≤ G2, then proceed to step #3
3^c	Maintenance	30mg 3 x week as a 2-hour IV infusion (Mon-Wed-Fri) for ≤ 12 weeks

^{a. Although not approved by Health Canada, alemtuzumab has been given subcutaneously instead of intravenously; the incidence of infusion reactions may be lower.}

b. Gradual dose escalation is required at the initiation of therapy and after treatment interruptions of 7 days or more. In most patients, escalation to 30mg can be accomplished in 3-7 days.

c. Single doses of alemtuzumab greater than 30mg or cumulative weekly doses of greater than 90mg should not be administered since higher doses are associated with an increased incidence of pancytopenia

C - Cycle Frequency

The treatment cycle is up to 12-13 weeks, including the initial dose and up to 12 weeks maintenance. No data available to support re-treatment with alemtuzumab; however, Rai et al. has considered re-treatment in appropriate patients who relapsed more than 1 year after initial treatment.

D - Premedication and Supportive Measures

Antiemetic Regimen:

Minimal (infusion-related event)

Other Supportive Care:

Diphenhydramine 50mg PO and acetaminophen 650mg PO 30 minutes before infusion; add meperidine 25mg IV and hydrocortisone 200mg IV with ≥ grade 3 reaction with prior infusion
Trimethoprim/sulfamethoxazole DS twice daily three times per week and famciclovir (or equivalent) 250mg bid during treatment and for 2 months after or until CD4+ count ≥ 200 cells/uL
Allopurinol and hydration to reduce the risk of tumour lysis syndrome are recommended.
Irradiated blood products should be used

E - Dose Modifications

Doses should be modified according to the protocol by which the patient is being treated. The following recommendations are in use at some centres.

Dosage with toxicity

Toxicity (grade or 10⁹)	1st Occurrence	2nd Occurrence	3rd Occurrence
ANC < 0.25 and/or platelet ≤ 25	Hold, restart at same dose when ANC ≥ 0.5 and platelets ≥ 50	Hold, restart at 10mg when ANC ≥ 0.5 and platelets ≥ 50	Discontinue
If baseline ANC ≤ 0.25, and/or platelet ≤ 25 and ↓ 50%	Hold, restart at same dose when ≥ baseline	Hold, restart at 10mg when ≥ baseline	Discontinue
≥ Grade 3 non-hematologic toxicity, including serious infections and CMV viremia	Hold until ≤ grade 2. Consider dose modification
≥ Grade 3 infusion reaction	Hold. Add meperidine and hydrocortisone as pre-medications.
Autoimmune disorders	Discontinue
PML, autoimmune anemia or thrombocytopenia	Discontinue
If delay between dosing is ≥ 7 days, must re-escalate starting from 3mg Do not modify dose for lymphopenia

Dosage in the Elderly: Limited experience; no dose modifications appear required.

Hepatic Impairment

No information found.

Renal Impairment

No information found.

F - Adverse Effects

Refer to alemtuzumab drug monograph(s) for additional details of adverse effects

Most Common Side Effects	Less Common Side Effects, but may be Severe or Life-Threatening
Myelosuppression +/- infection and bleeding (may be severe) Atypical infections Nausea, vomiting Hypersensitivity (may be severe) Rash	Arrhythmia Cardiotoxicity Tumor lysis syndrome ATE Nephrotoxicity VTE GI obstruction GI perforation DIC Cholecystitis Pancreatitis Pneumonitis Secondary malignancy Autoimmune disorders Transfusion associated GVHD

G - Interactions

Refer to alemtuzumab drug monograph(s) for additional details

H - Drug Administration and Special Precautions

Refer to alemtuzumab drug monograph(s) for additional details

I - Recommended Clinical Monitoring

Recommended Clinical Monitoring

Complete blood count (CBC) and platelets weekly and as needed
Clinical examination for infusion reactions, respiratory and cardiac events, autoimmune disorders, bleeding and infection
Consider CMV monitoring.
CD4+ counts should be assessed after treatment until recovery to ≥ 200cells/μL.
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

J - Administrative Information

Approximate Patient Visit

IV: 3 hours; SC: 1 hour

Pharmacy Workload (average time per visit)

8.334 minutes

Nursing Workload (average time per visit)

32.33 minutes

K - References

Lundin J, Kimby E, Bjorkholm M, et al. Phase II trial of subcutaneous anti-CD52 monoclonal antibody alemtuzumab (Campath-1H) as first-line treatment for patients with B-cell chronic lymphocytic leukemia (B-CLL). Blood 2002; 100: 768-773.

Hillmen P, Skotnicki AB, Robak T. Alemtuzumab compared with chlorambucil as first-line therapy for chronic lymphocytic leukemia. JCO 2007; 25(35): 5616-23.

Rai K, Freter CE, Mercier RJ, et al. Alemtuzumab in previously treated Chronic Lymphocytic Leukemia Patients who had also received fludarabine. JCO 2002; 20: 3891-97.

L - Other Notes

Alemtuzumab should be administered under the supervision of a physician experienced in the use of antineoplastic therapy in a setting where full resuscitation facilities are immediately available and personnel are experienced and capable of dealing with severe infusion-related reactions.

Ministry of Health and Long Term Care, Ontario Public Drug Program, decided not to fund alemtuzumab for the treatment of chronic lymphocytic leukemia (CLL) through Cancer Care Ontario’s New Drug Funding Program, on the basis that the evidence regarding its effectiveness is weak, and the value for-money of the drug is unclear.

(Decision document posted July 2007)

^{_{Feb 2012: Modified sections B, D, E, F, I.}}

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
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Last Updated: July 21, 2026

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