Autologous Stem Cell Transplant Clinical Trial
Official title:
Bendamustine, Cytarabine, Etoposide and Melphalan as Conditioning for Autologous Stem Cell Transplant in Patients With Aggressive Non Hodgkin's Lymphoma.
The purpose of this study is to determine whether Bendamustine in combination with Etoposide, Cytarabine and Melphalan (BeEAM) are effective as conditioning followed by ASCT in patients with aggressive lymphoma.
BCNU (carmustine is a nitrosurea alkylating agent used for many years in the conditioning of
patients with lymphoma however this drug is hardly available in some countries in Europe,
moreover to improve conditioning regimens in autologous stem cell transplant is important
because the anti-tumoral effect of high dose therapy are responsible for this procedure
efficacy. Although for many years few advances have been achieved in this area now new drugs
can be tested in these patients.
Bendamustine is a unique cytotoxic agent with structural similarities to alkylating agents
and antimetabolites, but which is non-cross-resistant with alkylating agents and other drugs
in vitro and in the clinic. Early clinical studies conducted in the German Democratic
Republic more than 30 years ago suggested promising activity in indolent non-Hodgkin's
lymphoma (NHL). Two North American trials reported responses in more than 70% of patients
with chemotherapy- and rituximab-refractory disease, suggesting that bendamustine may be the
most effective drug available for this patient population. Response rates of 90% to 92%,
with complete remission in 55% to 60%, have been reported in patients with follicular and
mantle-cell lymphoma with the combination of bendamustine and rituximab.(Cheson 2009) Leone
et all have recently reported results on the characterization of the mechanisms of action of
bendamustine and its comparison with structurally related compounds as chlorambucil and
phosphoramide mustard have demonstrated that bendamustine displays a distinct mechanisms of
action including activation of DNA-damage stress response and apoptosis, inhibition of
mitotic checkpoints, and induction of mitotic catastrophe. Also bendamustine activates a
base excision DNA repair pathway rather than an alkyltransferase DNA repair mechanism.
These data suggest that bendamustine possesses mechanistic features that differentiate it
from other alkylating agents and makes this old new drug an attractive one to combine with
other agents in the conditioning transplant setting (Leone 2008).
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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