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

Full Abstract

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.

Author information

Author/s: Angiolillo, Anne L (AL); Yu, Alice L (AL); Reaman, Gregory (G); Ingle, Ashish M (AM); Secola, Rita (R); Adamson, Peter C (PC);

Affiliation: Division of Oncology, Children's National Medical Center, Washington, District of Columbia 20010, USA. aangioli(-atsign-)cnmc.org

Grants: U-01 CA97452 (Agency:NCI NIH HHS) ; U-10 CA98543 (Agency:NCI NIH HHS)

Journal and publication information

Publication Type: Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't

Journal: Pediatric blood & cancer (Pediatr Blood Cancer), published in United States. (Language: eng)

Reference: 2009-Dec; vol 53 (issue 6) : pp 978-83

Dates: Created 2009/09/16; Completed 2009/10/13;

PMID: 19637330, status: MEDLINE (last retrieval date: 10/13/2009, IMS Date: )

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