Personalized Therapy of Precursor Lymphoid Neoplasms

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2012 by Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
Sponsor:
Collaborator:
Polish Adult Leukemia Group
Information provided by (Responsible Party):
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
ClinicalTrials.gov Identifier:
NCT01665001
First received: August 11, 2012
Last updated: August 16, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Precursor Lymphoid Neoplasms
Other: Treatment strategy: induction, consolidation, HSCT, maintenance
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice:

Primary Outcome Measures:
  • Overall survival [ Time Frame: three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Leukemia-free survival [ Time Frame: three years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Remission duration [ Time Frame: three years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
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)
Arms Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665001

Contacts
Contact: Sebastian Giebel, MD 0048322788523 sgiebel@io.gliwice.pl

Locations
Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch Not yet recruiting
Gliwice, Poland, 44-101
Contact: Sebastian Giebel, MD    0048322788523    sgiebel@io.gliwice.pl   
Sponsors and Collaborators
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
Polish Adult Leukemia Group
Investigators
Principal Investigator: Sebastian Giebel, MD Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland
  More Information

Additional Information:
Publications:
Responsible Party: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
ClinicalTrials.gov Identifier: NCT01665001     History of Changes
Other Study ID Numbers: PALG ALL6
Study First Received: August 11, 2012
Last Updated: August 16, 2012
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice:
Acute lymphoblastic leukemia
Induction
Consolidation
Minimal residual disease
Hematopoietic stem cell transplantation

Additional relevant MeSH terms:
Neoplasms
Neoplasm, Residual
Lymphoma, Non-Hodgkin
Neoplastic Processes
Pathologic Processes
Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014