Alemtuzumab (Campath)

General information

Class/mechanism: Anti-CD52 antibody that is believed to cause antibody-dependent cell-mediated cytotoxicity of cells that express the CD52 antigen on their surface: B and T lymphocytes, most monocytes, macrophages, natural killer (NK) cells, and a subpopulation of granulocytes.
Route: IV
Extravasation: neutral

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, Medscape, UpToDate (courtesy of Lexicomp), or the prescribing information.

Toxicity management

• Use of alemtuzumab (Lemtrada) requires participation in the Lemtrada REMS program.

Diseases for which it is used

• Adult T-cell leukemia-lymphoma
• Autoimmune cytopenia
• Chronic lymphocytic leukemia
• Cutaneous T-cell lymphoma
• Hypereosinophilic syndrome
• Myelodysplastic syndrome
• Peripheral T-cell lymphoma
• T-cell prolymphocytic leukemia
• Waldenström macroglobulinemia

Patient drug information

• Alemtuzumab (Campath) patient drug information (Chemocare)
• Brief patient counseling information can be found at the end of page 2 of the Alemtuzumab (Campath) package insert
• Alemtuzumab (Campath) patient drug information (UpToDate)

History of changes in FDA indication

• 2001-05-07: Initial accelerated approval for the treatment of patients with B-cell chronic lymphocytic leukemia who have been treated with alkylating agents and who have failed fludarabine therapy. (Based on Keating et al. 2002, Rai et al. 2002, and Lozanski et al. 2004)
  • 2007-09-19: Converted to regular approval and indication expanded to include use as a single agent for treatment of B-cell chronic lymphocytic leukemia (B-CLL) (Based on CAM 307)
• 2012-10: Genzyme withdraws drug from USA and EU (still available for B-CLL patients, however). See Lancet editorial.

History of changes in EMA indication

• 2001-07-06: Initial authorization for the treatment of patients with B-cell chronic lymphocytic leukaemia (B-CLL) for whom fludarabine combination chemotherapy is not appropriate.
• 2012-08-08: Authorization withdrawn at the request of the manufacturer, for commercial reasons

History of changes in PMDA indication

• 2014-09-26: Initial approval for the treatment of relapsed or refractory chronic lymphocytic leukemia.
• 2020-12-25: new indication and a new dosage for a conditioning regimen prior to allogeneic hematopoietic stem cell transplantation.

Also known as

• Code name: LDP03
• Brand names: Campath, Campath-1H, Lemtrada, MabCampath