Acute Lymphoblastic Leukemia Clinical Trial
Official title:
SAFETY AND EFFICACY OF PENTOXIFYLLINE VERSUS PLACEBO ADMINISTERED AS APOPTOSIS INDUCTOR DURING REMISSION INDUCTION PHASE OF PEDIATRIC PATIENTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA
Recent advances in acute lymphoblastic leukemia treatment are based on a cytotoxic drug
combination. Measurement of minimal residual disease in bone marrow samples at day 14 of
treatment is the most powerful early predictive indicator of further relapse, and it can be
applied practically to all patients with acute lymphoblastic leukemia. Even more so, it has
been observed that patients who present negative minimal residual disease in bone marrow
samples at day 7 during induction have a better prognosis than those achieving this at day
14.
Relapse represents the main cause of treatment failure that related in the extreme with
resistance to apoptosis, defining the latter as the principal mechanism of programmed cell
death; it is also related with the induction of leukemic cells to senescent arrest.
Pentoxifylline is a methyl-xanthine byproduct considered an unspecific inhibitor of
phosphodiesterase. It inhibits nuclear factor-kappa-beta activation by different mechanisms
and stimulates apoptosis induced by different drugs; thus, it can optimize the antineoplastic
effect of actual treatments in order to increase the apoptosis of leukemic cells. This effect
might improve the prognosis of these patients.
Evaluate the safety and effect of Pentoxifylline together with antineoplastic drugs in order
to study increased apoptosis and decreased senescence during the remission induction phase in
pediatric patients with newly diagnosed acute lymphoblastic leukemia. To achieve this
propose, we will divide patients in two groups, who will receive pentoxifylline or placebo
depending on the group, in addition to conventional treatment according to the protocol
standard chemotherapy schema for pediatric patients with acute lymphoblastic leukemia at our
institution during the remission induction phase. In addition, we will test whether the study
group exerts an impact on reaching remission earlier as compared with the control group.
This study will be controlled, double-blind clinical trial versus placebo, with random assignment to evaluate the effect of pentoxifylline on apoptosis and senescence of leukemic blasts from remission induction in pediatric patients with newly diagnosed acute lymphoblastic leukemia, as well as to address pentoxifylline efficacy and safety in this group of patients. ;
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