Personalized Therapy of Precursor Lymphoid Neoplasms

Sponsor

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice (Other)

Overall Status

Unknown status

CT.gov ID

NCT01665001

Collaborator

Polish Adult Leukemia Group (Other)

200

Enrollment

Location

Arm

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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

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

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Aug 1, 2012

Anticipated Primary Completion Date :

Aug 1, 2016

Anticipated Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Overall survival [three years]

Secondary Outcome Measures

Leukemia-free survival [three years]

Other Outcome Measures

Remission duration [three years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch	Gliwice		Poland	44-101

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