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Updated: Aug 4, 2026
Pre-clinical Evaluation of Tyrosine Kinase Inhibitors for Treatment of Acute Leukemia
Published on: September 18, 2013
Phase II study of gemcitabine in children with relapsed acute lymphoblastic leukemia or acute myelogenous leukemia
Anne L Angiolillo1, J Whitlock, Z Chen
1Children's National Medical Center, George Washington University, Washington, DC, District of Columbia, USA. aangioli@cnmc.org
Background:
To determine the response rate and toxicity to gemcitabine administered as 10 mg/m2/min x 360 min weekly for 3 weeks in children with relapsed acute lymphoblastic leukemia (ALL) or acute myelogenous leukemia (AML). Gemcitabine is a deoxycytidine analog that inhibits DNA synthesis and repair and has a broad spectrum of antitumor activity.
Procedure:
From April 2001 to April 2003, 23 male and 9 female eligible patients were recruited for the Children's Oncology Group (COG) phase II study of Gemcitabine (ADVL0022).
Results:
One of 20 evaluable patients with ALL and none of 10 evaluable patients with AML had complete responses to gemcitabine; there were no partial responses. Grade 3 or 4 hematologic toxicity and liver toxicity were common during therapy. Only one patient was alive 1 year after entry. The estimated 1-year overall survival probability for the 32 patients was 4% (SE = 3%).
Conclusions:
Gemcitabine at the dose and schedule in this trial was not effective for children with relapsed AML or ALL.
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