Personalized Therapy of Precursor Lymphoid Neoplasms
|Precursor Lymphoid Neoplasms||Other: Treatment strategy: induction, consolidation, HSCT, maintenance||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Overall survival [ Time Frame: three years ]
- Leukemia-free survival [ Time Frame: three years ]
- Remission duration [ Time Frame: three years ]
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||August 2018|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Experimental: Multiagent induction-consolidation
Induction, consolidation, HSCT, maintenance for adults with newly diagnosed precursor lymphoid neoplasms
Other: Treatment 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665001
|Contact: Sebastian Giebel, MDemail@example.com|
|Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch||Not yet recruiting|
|Gliwice, Poland, 44-101|
|Contact: Sebastian Giebel, MD 0048322788523 firstname.lastname@example.org|
|Principal Investigator:||Sebastian Giebel, MD||Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland|