Personalized Therapy of Precursor Lymphoid Neoplasms
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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 |
- Overall survival [ Time Frame: three years ] [ Designated as safety issue: No ]
- Leukemia-free survival [ Time Frame: three years ] [ Designated as safety issue: No ]
- 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 |
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| Contact: Sebastian Giebel, MD | 0048322788523 | sgiebel@io.gliwice.pl |
| 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 | |
| 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 Neoplastic Processes Pathologic Processes |
Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013