A Phase II Pilot Multicenter Study of Denileukin Diftitox Alone and in Combination With ICE (ICED) Chemotherapy in Children, Adolescents and Young Adults (CAYA) With Relapsed or Refractory Anaplastic Large Cell Lymphoma
Despite significant progress in the treatment and outcome for childhood ALCL, the prognosis
for children who develop progressive or recurrent disease is poor with < 30% DFS. Novel
therapies are urgently needed for these subgroups of patients. One potential approach is the
investigation of a new class of receptor targeted cytotoxic fusion proteins (denileukin
diftitox{DD}). We have previously demonstrated that > 85% of children with ALCL express
CD25. The human IL-2 receptor exists in three forms, low (CD25), intermediate (CD122/CD132)
and high (CD25/CD122/CD132) affinity. DD is a recombinant DNA-derived cytotoxic fusion
protein composed of the amino acid sequences for diphtheria toxin fragments followed by the
binding sequences for the interleukin-2 receptor. Malignant cells expressing one or more of
the subunits of the IL-2 receptor are found in certain leukemias and lymphomas including
cutaneous T-cell lymphoma (CTCL). Clinical studies have shown therapeutic efficacy of DD
alone and in combination with CHOP chemotherapy in CD25 expressing malignancies such as
CTCL, CLL and lymphoma. We hypothesize that DD will be safe and efficacious in children with
relapsed ALCL.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity
5 months
No
Mitchell S Cairo, MD
Principal Investigator
Columbia University
United States: Institutional Review Board
AAAC8963
NCT00801918
December 2008
June 2012
Name | Location |
---|---|
Columbia University Medical Center | New York, New York 10032 |