Precursor Lymphoid Neoplasms
Conditions
Keywords
Acute lymphoblastic leukemia, Induction, Consolidation, Minimal residual disease, Hematopoietic stem cell transplantation
Brief summary
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
Detailed description
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.
Interventions
OTHERTreatment strategy: induction, consolidation, HSCT, maintenance
Patients \<55 years Ph-neg.: induction (daunorubicin, prednisone, vincristin, PEG-asparaginase), 2nd induction (if non-remission or MRD\>0.1%; FLAM, MiniFLAM or FLAM-CAMP dependent on age and phenotype), consolidation (methotrexate, etoposide, cytarabine, cyclophosphamide, PEG-asparaginase). If MRD \<0.01%: autoHSCT + maintenance (mercaptopurine, methotrexate) or multiagent maintenance (additionally daunorubicin, vincristin, prednisone); remaining patients: alloHSCT. Prophylaxis of leptomeningeal involvement: liposomal cytarabine intrathecally. Patients \>55 years, Ph-neg.: as above, reduced doses. AlloHSCT with reduced conditioning. Patients Ph-pos.: as above, reduced doses in combination with continues imatinib. All intended for alloHSCT.
Sponsors
Polish Adult Leukemia Group
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* New diagnosis of PLN according to WHO 2008 classification * Age ≥18 years * Biological status allowing administration of induction therapy * Informed patient consent form signed
Exclusion criteria
* Pregnancy * Psychiatric diseases * History of other malignancies * HIV infection * Active hepatitis * Hypersensitivity to drugs used in induction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | three years |
Secondary
| Measure | Time frame |
|---|---|
| Leukemia-free survival | three years |
Other
| Measure | Time frame |
|---|---|
| Remission duration | three years |
Countries
Poland
Contacts
Primary ContactSebastian Giebel, MD
Outcome results
None listed