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Personalized Therapy of Precursor Lymphoid Neoplasms

NCT01665001 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2012-08-17

No results posted yet for this study

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

Conditions

  • Precursor Lymphoid Neoplasms

Interventions

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.

Sponsors & Collaborators

  • Polish Adult Leukemia Group

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Sebastian Giebel, MD · Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2016-08-31
Completion
2018-08-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01665001 on ClinicalTrials.gov