Phase II Pilot Efficacy Trial of the Combination Regimen Oncaspar/Doxil/Decadron (ODD) in Patients With Refractory Lymphoid Malignancies
This phase II trial will study the effectiveness of a combination regimen which includes
Oncaspar (PEG-asparaginase), Doxil (PEG-liposomal doxorubicin), and Decadron (ODD) in terms
of disease response against refractory lymphoid malignancies. Asparaginase is an enzyme
that depletes asparagines, a key amino acid for survival and growth of malignant
lymphocytes. Its depletion results in death of the neoplastic cell. Asparagine depletion
has induced a significant improvement of clinical outcomes in acute lymphoblastic leukemia
(ALL) and L-asparaginase has been a mainstay for more than 30 years in the treatment of ALL.
Although this drug has been used primarily in ALL, promising results have been reported even
in other non-ALL lymphoid malignancies, such as chronic lymphocytic leukemia (CLL),
prolymphocytic leukemia, refractory non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM).
One of the main goals of this trial is to measure the asparaginase level as a surrogate
marker of asparagine depletion with Oncaspar, a PEG-enhanced version of E. coli
L-asparaginase. The therapeutic value of the simple, non-pegylated form of L-asparaginase is
limited by its short half-life and propensity to cause allergic reactions.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Joseph J. Drabick, MD
Penn State University
United States: Institutional Review Board
|Penn State Milton S. Hershey Medical Center||Hershey, Pennsylvania 17033|