Personalized Therapy of Precursor Lymphoid Neoplasms

Phase 2

• Conditions: Precursor Lymphoid Neoplasms

• Registration Number: NCT01665001
• Lead Sponsor: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice

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.

Study Timeline

• Status Verified: 2012-08
• Study Start: 2012-08
• Study First Submitted: 2012-08-11
• Study First Submitted QC: 2012-08-14
• Study First Posted: 2012-08-15
• Last Update Submitted: 2012-08-16
• Last Update Posted: 2012-08-17
• Primary Completion: 2016-08
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall survival	three years

Secondary Outcome Measures

Name	Time	Method
Leukemia-free survival	three years

Trial Locations

Locations (1)

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch; 🇵🇱 Gliwice, Poland