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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Precursor Lymphoid Neoplasms

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

three years

Safety Issue:

No

Principal Investigator

Sebastian Giebel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Study ID:

PALG ALL6

NCT ID:

NCT01665001

Start Date:

August 2012

Completion Date:

August 2018

Related Keywords:

  • Precursor Lymphoid Neoplasms
  • Acute lymphoblastic leukemia
  • Induction
  • Consolidation
  • Minimal residual disease
  • Hematopoietic stem cell transplantation
  • Neoplasms
  • Neoplasm, Residual
  • Lymphoma

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