Precursor Lymphoid Neoplasms Clinical Trial
Official title:
Optimization of the Treatment of Adults With Precursor Lymphoid Neoplasms With Adjustment of the Type and Intensity of the Therapy for Age, Status of Minimal Residual Disease, Genetic and Phenotypic Features
The primary goal of this study by The Polish Adult Leukemia Group (PALG) is to verify if individual therapeutic approach taking into account biological and phenotypic differences as well as response at the level of minimal residual disease is associated with improved outcome of adults with precursor lymphoid neoplasms
Between 1997-2010 the PALG run three prospective studies. In the most recent PLAG 5-2007
protocol attempts have been made to individualize treatment. In particular, stratification
to high and standard risk group was based on both conventional clinical criteria and the
level of MRD after induction and consolidation. Patients with unsatisfactory response were
referred for allogeneic hematopoietic stem cell transplantation (alloHSCT). Interim analysis
showed significant improvement compared to previous PALG 4-2002 protocol with regard to both
overall survival and leukemia-free survival. The reasons of failure were relapses and
non-relapse mortality (NRM) associated with alloHSCT.
In the current protocol we intend to further adjust the therapy for individual patients
needs. We assume that this way we will be able to reduce the risk of relapse and NRM and
improve the cure rate. All patients will receive multiagent induction and consolidation
chemotherapy. The type and intensity of the therapy, as well as indications for allogeneic
and autologous HSCT will depend on age, status of MRD, immunophenotype and the presence of
BCR/ABL fusion gene.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment