Personalized Therapy of Precursor Lymphoid Neoplasms

Precursor Lymphoid Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01665001
• Other study ID #: PALG ALL6
• Status: Not yet recruiting
• Phase: Phase 2
• First received: August 11, 2012
• Last updated: August 16, 2012
• Start date: August 2012
• Est. completion date: August 2018

Study information

• Verified date: August 2012
• Source: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
• Contact: Sebastian Giebel, MD
• Phone: 0048322788523
• Email: sgiebel[@]io.gliwice.pl
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 2018
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lymphoma
• Neoplasm, Residual
• Neoplasms
• Precursor Lymphoid Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Poland	Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch	Gliwice

Sponsors (2)

Lead Sponsor	Collaborator
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice	Polish Adult Leukemia Group

Country where clinical trial is conducted

Poland, 

References & Publications (1)

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, Król 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Remission duration		three years	No
Primary	Overall survival		three years	No
Secondary	Leukemia-free survival		three years	No

External Links

•   The Polish Adult Leukemia Goup