Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2012-08-31
2018-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Multiagent induction-consolidation
Induction, consolidation, HSCT, maintenance for adults with newly diagnosed precursor lymphoid neoplasms
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years
* Biological status allowing administration of induction therapy
* Informed patient consent form signed
Exclusion Criteria
* Psychiatric diseases
* History of other malignancies
* HIV infection
* Active hepatitis
* Hypersensitivity to drugs used in induction
18 Years
ALL
No
Sponsors
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Polish Adult Leukemia Group
OTHER
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
OTHER
Responsible Party
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Principal Investigators
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Sebastian Giebel, MD
Role: PRINCIPAL_INVESTIGATOR
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland
Locations
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Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch
Gliwice, , Poland
Countries
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Central Contacts
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Facility Contacts
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Sebastian Giebel, MD
Role: primary
References
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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.
Related Links
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The Polish Adult Leukemia Goup
Other Identifiers
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PALG ALL6
Identifier Type: -
Identifier Source: org_study_id