Personalized Therapy of Precursor Lymphoid Neoplasms

Trial Title: Personalized Therapy of Precursor Lymphoid Neoplasms

NCT ID: NCT01665001

Condition: Precursor Lymphoid Neoplasms

Conditions: Official terms:
Neoplasms
Lymphoma

Conditions: Keywords:
Acute lymphoblastic leukemia
Induction
Consolidation
Minimal residual disease
Hematopoietic stem cell transplantation

Study type: Interventional

Study phase: Phase 2

Overall status: Unknown status

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Treatment strategy: induction, consolidation, HSCT, maintenance
Description: 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.
Arm group label: Multiagent induction-consolidation

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.

Criteria for eligibility:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch

Address:
City: Gliwice
Zip: 44-101
Country: Poland

Contact:
Last name: Sebastian Giebel, MD

Phone: 0048322788523
Email: sgiebel@io.gliwice.pl

Start date: August 2012

Completion date: August 2018

Lead sponsor:
Agency: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
Agency class: Other

Collaborator:
Agency: Polish Adult Leukemia Group
Agency class: Other

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

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01665001
http://palg.witaj.pl