Personalized Therapy of Precursor Lymphoid Neoplasms

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice

Status and phase: Unknown; Phase 2

Conditions: Precursor Lymphoid Neoplasms

Treatments: Other: Treatment strategy: induction, consolidation, HSCT, maintenance

Study type: Interventional

Funder types: Other

Identifiers

NCT01665001

PALG ALL6

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Multiagent induction-consolidation

Experimental group

Description:

Induction, consolidation, HSCT, maintenance for adults with newly diagnosed precursor lymphoid neoplasms

Treatment:

Other: Treatment strategy: induction, consolidation, HSCT, maintenance