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Personalized Therapy of Precursor Lymphoid Neoplasms
Conditions
Precursor Lymphoid Neoplasms
Conditions: official terms
Lymphoma - Neoplasm, Residual - Neoplasms
Conditions: Keywords
Acute lymphoblastic leukemia, Induction, Consolidation, Minimal residual disease, Hematopoietic stem cell transplantation
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Treatment strategy: induction, consolidation, HSCT, maintenance
Type: Other
Overall Status
Not yet recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
- 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
Location
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch
Gliwice, Poland
Status: Not yet recruiting
Contact: Sebastian Giebel, MD - 0048322788523 - sgiebel@io.gliwice.pl
Start Date
August 2012
Completion Date
August 2018
Sponsors
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
Source
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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