Efficacy
Campath® (alemtuzumab) achieved overall response rates from 21% to 33% in fludarabine-refractory B-CLL* in 3 multicenter studies.1-3
| |
Keating et al1(N=93) |
Rai et al2(N=32) |
Rai et al3(N=24) |
| Overall response rate |
33% |
21% |
29% |
| (95% confidence interval) |
(23%, 43%) |
(8%, 33%) |
(11%, 47%) |
| Complete response |
2% |
0% |
0% |
| Partial response |
31% |
21% |
29% |
| Median duration of response (months) |
7 |
7 |
11 |
| (95% confidence interval) |
(5, 8) |
(5, 23) |
(6, 19) |
| Median time to response (months) |
2 |
4 |
4 |
| (95% confidence interval) |
(1, 2) |
(1, 5) |
(2, 4) |
| Progression-free survival (months) |
4 |
5 |
7 |
| (95% confidence interval) |
(3, 5) |
(3, 7) |
(3, 9) |
Information source: Campath Full Prescribing Information.
*Fludarabine-refractory B-CLL patients were previously treated with alkylating agents.
Patient response in 3 multicenter studies1-3
Campath is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).
WARNING: CYTOPENIAS, INFUSION REACTIONS, and INFECTIONS
Cytopenias: Serious, including fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia can occur in patients receiving Campath. Single doses of Campath greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia [see WARNINGS AND PRECAUTIONS (5.1)].
Infusion Reactions: Campath administration can result in serious, including fatal, infusion reactions. Carefully monitor patients during infusions and withhold Campath for Grade 3 or 4 infusion reactions. Gradually escalate Campath to the recommended dose at the initiation of therapy and after interruption of therapy for 7 or more days [see DOSAGE AND ADMINISTRATION (2) and WARNINGS AND PRECAUTIONS (5.2)].
Infections: Serious, including fatal, bacterial, viral, fungal, and protozoan infections can occur in patients receiving Campath. Administer prophylaxis against Pneumocystis jiroveci pneumonia (PCP) and herpes virus infections [see DOSAGE AND ADMINISTRATION (2.2) and WARNINGS AND PRECAUTIONS (5.3)].
The most commonly reported adverse reactions are infusion reactions fever, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anemia), and infections (CMV viremia, CMV infection, other infections). In clinical trials, the frequency of infusion reactions was highest in the first week of treatment. Other commonly reported adverse reactions include vomiting, abdominal pain, insomnia and anxiety. The most commonly reported serious adverse reactions are cytopenias, infusion reactions, and immunosuppression/infections. See "Warnings and Precautions," and "Adverse Reactions" sections of full Prescribing Information.
Please see Full Prescribing Information (PDF).
