Clinical trial NCT01665001: Personalized Therapy of Precursor Lymphoid Neoplasms
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Precursor Lymphoid Neoplasms
Keywords: Acute lymphoblastic leukemia
Induction
Consolidation
Minimal residual disease
Hematopoietic stem cell transplantation
Lead sponsor: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
Sponsor class: OTHER
Collaborators: name: Polish Adult Leukemia Group
First posted: 2012-08-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall survival
timeFrame: three years
Secondary outcomes:
measure: Leukemia-free survival
timeFrame: three years
Other outcomes:
measure: Remission duration
timeFrame: three years
Locations:
city: Gliwice
country: Poland
facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch
Study officials:
affiliation: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland
name: Sebastian Giebel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holowiecki J, Krawczyk-Kulis M, Giebel S, Jagoda K, Stella-Holowiecka B, Piatkowska-Jakubas B, Paluszewska M, Seferynska I, Lewandowski K, Kielbinski M, Czyz A, Balana-Nowak A, Krol M, Skotnicki AB, Jedrzejczak WW, Warzocha K, Lange A, Hellmann A. Status of minimal residual disease after induction predicts outcome in both standard and high-risk Ph-negative adult acute lymphoblastic leukaemia. The Polish Adult Leukemia Group ALL 4-2002 MRD Study. Br J Haematol. 2008 Jun;142(2):227-37. doi: 10.1111/j.1365-2141.2008.07185.x. Epub 2008 May 19.