<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01665001</url>
  </required_header>
  <id_info>
    <org_study_id>PALG ALL6</org_study_id>
    <nct_id>NCT01665001</nct_id>
  </id_info>
  <brief_title>Personalized Therapy of Precursor Lymphoid Neoplasms</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Polish Adult Leukemia Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary goal of this study by The Polish Adult Leukemia Group (PALG) is to verify if&#xD;
      individual therapeutic approach taking into account biological and phenotypic differences as&#xD;
      well as response at the level of minimal residual disease is associated with improved outcome&#xD;
      of adults with precursor lymphoid neoplasms&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Between 1997-2010 the PALG run three prospective studies. In the most recent PLAG 5-2007&#xD;
      protocol attempts have been made to individualize treatment. In particular, stratification to&#xD;
      high and standard risk group was based on both conventional clinical criteria and the level&#xD;
      of MRD after induction and consolidation. Patients with unsatisfactory response were referred&#xD;
      for allogeneic hematopoietic stem cell transplantation (alloHSCT). Interim analysis showed&#xD;
      significant improvement compared to previous PALG 4-2002 protocol with regard to both overall&#xD;
      survival and leukemia-free survival. The reasons of failure were relapses and non-relapse&#xD;
      mortality (NRM) associated with alloHSCT.&#xD;
&#xD;
      In the current protocol we intend to further adjust the therapy for individual patients&#xD;
      needs. We assume that this way we will be able to reduce the risk of relapse and NRM and&#xD;
      improve the cure rate. All patients will receive multiagent induction and consolidation&#xD;
      chemotherapy. The type and intensity of the therapy, as well as indications for allogeneic&#xD;
      and autologous HSCT will depend on age, status of MRD, immunophenotype and the presence of&#xD;
      BCR/ABL fusion gene.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">August 2018</completion_date>
  <primary_completion_date type="Anticipated">August 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>three years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Leukemia-free survival</measure>
    <time_frame>three years</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Remission duration</measure>
    <time_frame>three years</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Precursor Lymphoid Neoplasms</condition>
  <arm_group>
    <arm_group_label>Multiagent induction-consolidation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Induction, consolidation, HSCT, maintenance for adults with newly diagnosed precursor lymphoid neoplasms</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment strategy: induction, consolidation, HSCT, maintenance</intervention_name>
    <description>Patients &lt;55 years Ph-neg.: induction (daunorubicin, prednisone, vincristin, PEG-asparaginase), 2nd induction (if non-remission or MRD&gt;0.1%; FLAM, MiniFLAM or FLAM-CAMP dependent on age and phenotype), consolidation (methotrexate, etoposide, cytarabine, cyclophosphamide, PEG-asparaginase). If MRD &lt;0.01%: autoHSCT + maintenance (mercaptopurine, methotrexate) or multiagent maintenance (additionally daunorubicin, vincristin, prednisone); remaining patients: alloHSCT. Prophylaxis of leptomeningeal involvement: liposomal cytarabine intrathecally.&#xD;
Patients &gt;55 years, Ph-neg.: as above, reduced doses. AlloHSCT with reduced conditioning.&#xD;
Patients Ph-pos.: as above, reduced doses in combination with continues imatinib. All intended for alloHSCT.</description>
    <arm_group_label>Multiagent induction-consolidation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  New diagnosis of PLN according to WHO 2008 classification&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Biological status allowing administration of induction therapy&#xD;
&#xD;
          -  Informed patient consent form signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Psychiatric diseases&#xD;
&#xD;
          -  History of other malignancies&#xD;
&#xD;
          -  HIV infection&#xD;
&#xD;
          -  Active hepatitis&#xD;
&#xD;
          -  Hypersensitivity to drugs used in induction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sebastian Giebel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sebastian Giebel, MD</last_name>
    <phone>0048322788523</phone>
    <email>sgiebel@io.gliwice.pl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch</name>
      <address>
        <city>Gliwice</city>
        <zip>44-101</zip>
        <country>Poland</country>
      </address>
    </facility>
    <contact>
      <last_name>Sebastian Giebel, MD</last_name>
      <phone>0048322788523</phone>
      <email>sgiebel@io.gliwice.pl</email>
    </contact>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <link>
    <url>http://palg.witaj.pl</url>
    <description>The Polish Adult Leukemia Goup</description>
  </link>
  <reference>
    <citation>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.</citation>
    <PMID>18492099</PMID>
  </reference>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 11, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>August 16, 2012</last_update_submitted>
  <last_update_submitted_qc>August 16, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 17, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute lymphoblastic leukemia</keyword>
  <keyword>Induction</keyword>
  <keyword>Consolidation</keyword>
  <keyword>Minimal residual disease</keyword>
  <keyword>Hematopoietic stem cell transplantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Lymphoma</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01665001
org study id: PALG ALL6
nct id: NCT01665001
lead sponsor: 
collaborator: 
has dmc: Yes
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
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival
time frame: three years
measure: Leukemia-free survival
time frame: three years
measure: Remission duration
time frame: three years
arm group label: Multiagent induction-consolidation
arm group type: Experimental
description: Induction, consolidation, HSCT, maintenance for adults with newly diagnosed precursor lymphoid neoplasms
intervention type: Other
intervention name: Treatment strategy: induction, consolidation, HSCT, maintenance
description: 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 group label: Multiagent induction-consolidation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sebastian Giebel, MD
role: Principal Investigator
affiliation: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland
last name: Sebastian Giebel, MD
phone: 0048322788523
email: sgiebel@io.gliwice.pl
facility: 
contact: 
country: Poland
url: http://palg.witaj.pl
description: The Polish Adult Leukemia Goup
citation: 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.
PMID: 18492099
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Lymphoma