Precursor Cell Lymphoblastic Leukemia-Lymphoma Clinical Trial
Official title:
Phase 2 Study Evaluating the Efficacy of Rituximab Plus Modified VPDL for Newly Diagnosed CD20-Positive Adult Acute Lymphoblastic Leukemia
The investigators would like to propose a phase-2 prospective multicenter trial evaluating the efficacy of rituximab combination with our current chemotherapy strategy for adult Acute Lymphoblastic Leukemia (ALL), in order to prove out whether the addition of rituximab during induction, consolidation, and post-alloHCT status can improve the outcome in terms of relapse-free survival (RFS) when compared with our prior data as a historical control.
According to the recent results on the outcome of escalated daunorubicin-based protocol for
adult ALL which has been performed by 'Adult ALL Working Party of the Korean Society of
Hematology' (data were announced at 2010 Annual Meeting of ASCO, Chicago, IL), CR rate of
90.6% was satisfactory, but the 2-year / 3-year disease-free survival (DFS) were
disappointing (43.6% and 39.9%, respectively), which means that the adequate post-remission
therapy to control minimal residual disease after the achievement of CR is very important to
improve the outcome of adult ALL.
Allogeneic hematopoietic cell transplantation (AlloHCT) is recommended as a post-remission
therapy for patients with adult ALL, and reduced intensity conditioning has been tried to
decrease TRM rate. However, many patients received consolidation chemotherapy rather than
alloHCT owing to the absence of HLA-matched donor, limitation of age, and combined
comorbidities (among 190 patients who have been included in our previously-mentioned study,
only 52.3% received alloHCT).
Recently, stagnation in the treatment of adult ALL appears to be reached, maybe due to a
borderline for further intensification of chemotherapeutic dose. Dose-escalation strategy has
many difficulties in adoption for the treatment of adult ALL in terms of increased morbidity
and mortality, not to mention the efficacy of such strategies. New, preferably
non-chemotherapy approaches (maybe targeted therapy) are therefore urgently required.
For Ph(+) ALL, the introduction of BCR/ABL tyrosine kinase inhibitor has improved the
treatment outcome with tolerable toxicities. Applying a similar strategy to Ph(-) ALL,
targeting leukemia surface antigens with monoclonal antibodies is another promising strategy.
CD 20 expression of at least 20% has been known to be found in 22-48% of pre-B ALL, and
appears to be associated with a poor prognosis, although there are controversies in pediatric
patients. Based on the significant improvement of the outcome in B-cell NHL, preliminary data
regarding the use of rituximab in frontline therapy for CD20-positive precursor B-cell ALL
suggest its use may be beneficial. Especially, monoclonal antibodies are thought to be more
effective when combined with chemotherapy and treated in the state of minimal residual
disease, which suggests the interest of evaluating rituximab combined to current chemotherapy
of adult ALL. Recent data on the efficacy of rituximab-combined chemotherapy showed that
rates of CR and OS were superior with the modified hyperCVAD and rituximab regimens compared
with standard hyper-CVAD (70% versus 38%, p<0.001) in younger (age < 60 years) CD20-positive
subset, although it was an analysis of different patient groups who were treated with various
regimen5.
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