A phase II study of Campath-1H in children with relapsed or refractory acute lymphoblastic leukemia: a Children's Oncology Group report

Pediatr Blood Cancer. 2009 Dec;53(6):978-83. doi: 10.1002/pbc.22209.


Background: Despite the increasing cure rates for children with acute lymphoblastic leukemia (ALL), patients who relapse continue to have poor prognosis. The Children's Oncology Group (COG) conducted a limited institution Phase II trial of Campath-1H, a monoclonal antibody that targets CD52 on leukemic cells, in children with relapsed or refractory ALL.

Methods: From October 2005 to December 2006, 13 eligible patients were enrolled on the COG phase II study of Campath-1H (ADVL0222). Campath-1H was initially administered as an intravenous infusion over 2 hr, five times per week for 1 week, then three times per week for three additional weeks. Patients with stable disease or better on day 29 could continue on to combination therapy with Campath-1H, methotrexate, and 6-mercaptopurine for two additional cycles.

Results: One of 13 patients enrolled had a complete response to Campath-1H and 4 had stable disease. Dose limiting toxicity occurred in two out of nine fully evaluable patients (Grade IV pain and Grade III allergic reaction/hypersensitivity). No patients received combination therapy. Serum Campath-1H concentrations appeared to be somewhat lower in children with ALL compared with adult patients with chronic lymphocytic leukemia.

Conclusion: Although a single complete response was observed, activity of single agent Campath-1H appears limited. Our study does not support future single agent evaluation of Campath-1H in children with relapsed ALL.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Alemtuzumab
  • Antibodies, Monoclonal / administration & dosage*
  • Antibodies, Monoclonal / pharmacokinetics
  • Antibodies, Monoclonal / toxicity
  • Antibodies, Monoclonal, Humanized
  • Antibodies, Neoplasm / administration & dosage*
  • Antibodies, Neoplasm / toxicity
  • Antineoplastic Agents / administration & dosage
  • Child
  • Child, Preschool
  • Female
  • Humans
  • Male
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma / diagnosis
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma / drug therapy*
  • Salvage Therapy
  • Treatment Failure
  • Treatment Outcome
  • Young Adult


  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Antibodies, Neoplasm
  • Antineoplastic Agents
  • Alemtuzumab