<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/NCT02983097</url>
  </required_header>
  <id_info>
    <org_study_id>DSHNHL 2008 R6</org_study_id>
    <secondary_id>2009-010824-25</secondary_id>
    <nct_id>NCT02983097</nct_id>
  </id_info>
  <brief_title>Therapy of Non-Hodgkin-Lymphoma by Combination of Lenalidomide + Rituximab, Dexa, High-dose ARA-C and CisP</brief_title>
  <acronym>R²-DHAP</acronym>
  <official_title>Open-label, Multicenter Phase I/II Study: Salvage Therapy of Progressive and Relapsed Aggressive Non-Hodgkin-Lymphoma by Combination of Lenalidomide (Revlimid®) With Rituximab, Dexamethason, High-dose ARA-C and Cisplatinum (R²-DHAP)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Celgene</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to evaluate efficacy and safety of the combination of lenalidomide,&#xD;
      an immunomodulatory drug (IMiD) with a standard immunochemotherapy treatment, called R-DHAP.&#xD;
      R-DHAP consists of a monoclonal antibody called Rituximab and chemotherapy consisting of&#xD;
      Dexamethasone, high dose Cytarabine, often called Ara-C, and platinum based chemotherapy,&#xD;
      either cisplatinum, or, if treatment with cisplatinum is contraindicated, carboplatinum.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase 1/2 study to evaluate the efficacy and safety of lenalidomide added to a&#xD;
      standard chemotherapy regime of R-DHAP (Rituximab, Dexamethasone, high-dose Cytarabine,&#xD;
      Cis/Carboplatinum) in the treatment of relapsed or refractory high-grade B-cell&#xD;
      non-hodgkin-lymphoma (NHL).&#xD;
&#xD;
      The study hypothesis is that the combination of lenalidomide with standard immunochemotherapy&#xD;
      will lead to an overall response rate of at least 60%. In this study, 3 rounds of&#xD;
      immunochemotherapy in combination with lenalidomide will be administered. After the first or&#xD;
      second round of therapy, peripheral hematopoetic stem cells will be harvested. Consolidation&#xD;
      treatment with autologous or allogenic peripheral blood stem cell transplantation is&#xD;
      recommended in all patients suitable, but is not part of the study.&#xD;
&#xD;
      In phase 1, up to six cohorts of at least 6 patients each will be treated with the study&#xD;
      therapy, with lenalidomide in increasing dosages, to determine the maximum tolerated dose&#xD;
      (MTD).&#xD;
&#xD;
      In phase 2, 50 patients will be treated with the MTD. Efficacy and safety will be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Phase II: no scientific interests are given anymore&#xD;
  </why_stopped>
  <start_date>November 2010</start_date>
  <completion_date type="Actual">April 28, 2015</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>Phase 1/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 Response Rate (ORR)</measure>
    <time_frame>78 - 85 days + 2 years Follow Up</time_frame>
    <description>The percentage of patients which showed either a partial remission (PR), a complete remission with remaining uncertainty (CRu) or a complete remission (CR) after study treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum tolerated dose (MTD)</measure>
    <time_frame>78 - 85 days</time_frame>
    <description>The maximum dose of lenalidomide tolerated with acceptable toxicity during phase 1 of this study. The MTD established in phase 1 of this study will be administered to 50 patients in phase 2 of this study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of complete remission</measure>
    <time_frame>78 - 85 days + 2 years Follow Up</time_frame>
    <description>laboratory, BM biopsy, imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of primary progression</measure>
    <time_frame>78 - 85 days + 2 years Follow Up</time_frame>
    <description>The rate of patients which show progressive disease (PD) during or directly after study therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of treatment related deaths</measure>
    <time_frame>78 - 85 days + 2 years Follow Up</time_frame>
    <description>check survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse Rate</measure>
    <time_frame>78 - 85 days + 2 years Follow Up</time_frame>
    <description>laboratory, BM biopsy, imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>78 - 85 days + 2 years Follow Up</time_frame>
    <description>check survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>78 - 85 days + 2 years Follow Up</time_frame>
    <description>laboratory, BM biopsy, imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tumour control</measure>
    <time_frame>78 - 85 days + 2 years Follow Up</time_frame>
    <description>laboratory, BM biopsy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>feasibility of stem cell mobilization</measure>
    <time_frame>78 - 85 days + 2 years Follow Up</time_frame>
    <description>The collection of peripheral stem cells is needed to be able to offer the patient high dose chemotherapy followed by autologous stem cell transplantation after the study treatment has ended.&#xD;
Stem cell collection of &lt;2.0 *10e6 CD34+cells/kg will be considered insufficient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of non-hematological toxicities &gt; grade 2 CTC</measure>
    <time_frame>78 - 85 days + 2 years Follow Up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence and duration of neutropenia and thrombopenia grade 4</measure>
    <time_frame>78 - 85 days + 2 years Follow Up</time_frame>
    <description>laboratory WBC &lt; 1.0 /nl or Plt &lt; 25 /nl</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Diffuse Large B-cell Lymphoma (DLBCL)</condition>
  <condition>Follicular Lymphoma Grade III (FL III°)</condition>
  <condition>Mantle Cell Lymphoma (MCL), Blastoid Variant</condition>
  <condition>Burkitt Lymphoma (BL)</condition>
  <condition>Aggressive Marginal Zone Lymphoma (MZL)</condition>
  <arm_group>
    <arm_group_label>R²-DHAP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combination treatment with immunochemotherapy (R-DHAP) and lenalidomide&#xD;
Dosage:&#xD;
Rituximab 375 mg/m² day 1, i.v. Cisplatin 100 mg/m² or Carboplatin AUC5 day 2, i.v. Cytarabine 2000 mg/m², administered twice, on day 3, i.v. Dexamethasone 40 mg, days 2-5, p.o. Lenalidomide 5-20 mg, day 1-7 / day-6-+7, p.o. PEG-Filgrastim 6 mg, day 6, s.c.&#xD;
peripheral stem cell collection after cycle 1 or 2</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>Rituximab 375 mg/m²</description>
    <arm_group_label>R²-DHAP</arm_group_label>
    <other_name>MabThera</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>Cisplatinum 100 mg / m²</description>
    <arm_group_label>R²-DHAP</arm_group_label>
    <other_name>Cisplatinum</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Carboplatinum AUC5</description>
    <arm_group_label>R²-DHAP</arm_group_label>
    <other_name>Carboplatinum</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Dexamethasone 40 mg</description>
    <arm_group_label>R²-DHAP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cytarabine</intervention_name>
    <description>Cytarabine 2000 mg/m², administered twice</description>
    <arm_group_label>R²-DHAP</arm_group_label>
    <other_name>Cytarabin</other_name>
    <other_name>Ara-C</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lenalidomide</intervention_name>
    <description>5-20 mg administered either d1-d7, or d-6-d7</description>
    <arm_group_label>R²-DHAP</arm_group_label>
    <other_name>Revlimid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PegFilgrastim</intervention_name>
    <description>PegFilgrastim 6 mg</description>
    <arm_group_label>R²-DHAP</arm_group_label>
    <other_name>Neulasta</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>peripheral stem cell collection</intervention_name>
    <description>collection of peripheral stem cells for autologous stem cell transplantation</description>
    <arm_group_label>R²-DHAP</arm_group_label>
    <other_name>peripheral stem cell apheresis</other_name>
    <other_name>hematopoetic stem cell apheresis</other_name>
    <other_name>peripheral hematopoetic stem cell apheresis</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Age: 18-70&#xD;
&#xD;
        Risk groups: All risk groups&#xD;
&#xD;
        histology: diagnosis or a recurrent or primary progressive aggressive b-cell non-hodgkin&#xD;
        lymphoma, in particular&#xD;
&#xD;
          -  follicular lymphoma grade III&#xD;
&#xD;
          -  diffuse large b-cell lymphoma&#xD;
&#xD;
          -  burkitt lymphoma&#xD;
&#xD;
          -  mantle cell lymphoma, blastoid variant&#xD;
&#xD;
          -  aggressive marginal zone lymphoma&#xD;
&#xD;
        Performance status: ECOG 0-2&#xD;
&#xD;
        Criteria for women of childbearing potential:&#xD;
&#xD;
        Women of childbearing potential have to:&#xD;
&#xD;
          -  understand the teratogenic risk associated with the study therapy, especially&#xD;
             lenalidomide&#xD;
&#xD;
          -  understand the need of reliable, uninterrupted birth control from 4 weeks prior to the&#xD;
             start of the study drug, during the duration of the study treatment, and 4 weeks after&#xD;
             completion of study treatment, and be able to reliably use birth control, except if&#xD;
             the patient commits to absolute sexual abstinence, confirmed on a monthly basis&#xD;
&#xD;
        The following are effective methods of contraception:&#xD;
&#xD;
          -  implant&#xD;
&#xD;
          -  levonorgestrel-releasing intrauterine system (IUS)&#xD;
&#xD;
          -  medroxyprogesterone acetate depot&#xD;
&#xD;
          -  tubal sterilisation&#xD;
&#xD;
          -  sexual intercourse with a vasectomised male partner only, vasectomy must be confirmed&#xD;
             by two negative semen analyses&#xD;
&#xD;
          -  ovulation-inhibitory progesterone-only pills If not established on effective&#xD;
             contraception, the female subject must be referred to an appropriately trained health&#xD;
             care professional for contraceptive advice in order that contraception can be&#xD;
             initiated.&#xD;
&#xD;
          -  Understand that even if she has amenorrhea, she must follow all the advice on&#xD;
             effective contraception&#xD;
&#xD;
          -  Understand the potential consequences of pregnancy and the need to rapidly consult if&#xD;
             there is a risk of pregnancy.&#xD;
&#xD;
          -  Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25&#xD;
             mIU/ml on the day of the study visit or in the 3 days prior to the study visit once&#xD;
             the subject has been on effective contraception for at least 4 weeks. This requirement&#xD;
             also applies to women of childbearing potential who practice complete and continued&#xD;
             abstinence. The test should ensure the subject is not pregnant when she starts&#xD;
             treatment.&#xD;
&#xD;
          -  Agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks&#xD;
             after the end of study treatment, except in the case of confirmed tubal sterilization.&#xD;
             These pregnancy tests should be performed on the day of the study visit or in the 3&#xD;
             days prior to the study visit. This requirement also applies to women of childbearing&#xD;
             potential who practice complete and continued abstinence.&#xD;
&#xD;
        Male patients have to:&#xD;
&#xD;
          -  Agree to use condoms throughout study drug therapy, during any dose interruption and&#xD;
             for one week after cessation of study therapy if their partner is of childbearing&#xD;
             potential and has no contraception.&#xD;
&#xD;
          -  Agree not to donate semen during study drug therapy and for one week after end of&#xD;
             study drug therapy.&#xD;
&#xD;
        All patients have to:&#xD;
&#xD;
          -  Agree to abstain from donating blood while taking study drug therapy and for one week&#xD;
             following discontinuation of study drug therapy.&#xD;
&#xD;
          -  Agree not to share study medication with another person and to return all unused study&#xD;
             drug to the investigator&#xD;
&#xD;
        Patients must be able to take low molecular weight heparin as prophylactic anticoagulation&#xD;
&#xD;
        Written informed consent is necessary&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant or lactating females&#xD;
&#xD;
          -  already initiated salvage lymphoma therapy (except prephase as specified in this&#xD;
             study)&#xD;
&#xD;
          -  serious accompanying disorder or impaired organ function causing significant clinical&#xD;
             problems and reduced lyfe expectancy, in particular: heart: angina pectoris CCS&gt;2&#xD;
             cardiac failure NYHA&gt;2 and/or EF&lt;45% lungs: FeV1&lt;60%, diffusion capacity &lt;50% of the&#xD;
             reference values kidneys: creatinine&gt;2 times the upper reference limit liver:&#xD;
             bilirubin &gt;2 times the upper reference limit&#xD;
&#xD;
          -  platelets &lt;80000/mm³, leukocytes &lt;2500/³&#xD;
&#xD;
          -  CNS involvement of lymphoma&#xD;
&#xD;
          -  known hypersensitivity to the medications to be used&#xD;
&#xD;
          -  known HIV-positivity&#xD;
&#xD;
          -  suspicion that patient compliance will be poor, especially that rules for effective&#xD;
             contraception will not be followed&#xD;
&#xD;
          -  simultaneous participation in other treatment studies&#xD;
&#xD;
          -  non-conformity to eligibility criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bertram Glaß, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AK St.Georg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Diakonie Krankenhaus Bremen</name>
      <address>
        <city>Bremen</city>
        <zip>28239</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Chemnitz</name>
      <address>
        <city>Chemnitz</city>
        <zip>09113</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Essen</name>
      <address>
        <city>Essen</city>
        <zip>45122</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Frankfurt/Oder</name>
      <address>
        <city>Frankfurt/Oder</city>
        <zip>15236</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Göttingen</name>
      <address>
        <city>Göttingen</city>
        <zip>37075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik St. Georg</name>
      <address>
        <city>Hamburg</city>
        <zip>20099</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik Altona</name>
      <address>
        <city>Hamburg</city>
        <zip>22763</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum des Saarlandes</name>
      <address>
        <city>Homburg</city>
        <zip>66421</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westpfalz Klinikum</name>
      <address>
        <city>Kaiserslautern</city>
        <zip>67665</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Städtisches Klinikum Karlsruhe</name>
      <address>
        <city>Karlsruhe</city>
        <zip>76133</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LMU Klinikum München-Großhadern</name>
      <address>
        <city>München</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.lymphome.de/</url>
    <description>Homepage of the &quot;Kompetenznetz Maligne Lymphome&quot;</description>
  </link>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 14, 2013</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>January 17, 2018</last_update_submitted>
  <last_update_submitted_qc>January 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>lymphoma</keyword>
  <keyword>relapse</keyword>
  <keyword>recurrence</keyword>
  <keyword>progress</keyword>
  <keyword>progressive</keyword>
  <keyword>b-cell lymphoma</keyword>
  <keyword>chemotherapy</keyword>
  <keyword>immunotherapy</keyword>
  <keyword>IMiD</keyword>
  <keyword>Salvage chemotherapy</keyword>
  <keyword>peripheral stem cell mobilization</keyword>
  <keyword>lenalidomide</keyword>
  <keyword>Rituximab</keyword>
  <keyword>CD20</keyword>
  <keyword>Cytarabine</keyword>
  <keyword>Ara-C</keyword>
  <keyword>platinum-based chemotherapy</keyword>
  <keyword>Cisplatin</keyword>
  <keyword>Carboplatin</keyword>
  <keyword>Cisplatinum</keyword>
  <keyword>Carboplatinum</keyword>
  <keyword>Dexamethasone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burkitt Lymphoma</mesh_term>
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
    <mesh_term>Lymphoma, Mantle-Cell</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
    <mesh_term>Aggression</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cytarabine</mesh_term>
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Rituximab</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Lenalidomide</mesh_term>
  </intervention_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/NCT02983097
org study id: DSHNHL 2008 R6
secondary id: 2009-010824-25
nct id: NCT02983097
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The goal of this study is to evaluate efficacy and safety of the combination of lenalidomide,
      an immunomodulatory drug (IMiD) with a standard immunochemotherapy treatment, called R-DHAP.
      R-DHAP consists of a monoclonal antibody called Rituximab and chemotherapy consisting of
      Dexamethasone, high dose Cytarabine, often called Ara-C, and platinum based chemotherapy,
      either cisplatinum, or, if treatment with cisplatinum is contraindicated, carboplatinum.
This is a phase 1/2 study to evaluate the efficacy and safety of lenalidomide added to a
      standard chemotherapy regime of R-DHAP (Rituximab, Dexamethasone, high-dose Cytarabine,
      Cis/Carboplatinum) in the treatment of relapsed or refractory high-grade B-cell
      non-hodgkin-lymphoma (NHL).

      The study hypothesis is that the combination of lenalidomide with standard immunochemotherapy
      will lead to an overall response rate of at least 60%. In this study, 3 rounds of
      immunochemotherapy in combination with lenalidomide will be administered. After the first or
      second round of therapy, peripheral hematopoetic stem cells will be harvested. Consolidation
      treatment with autologous or allogenic peripheral blood stem cell transplantation is
      recommended in all patients suitable, but is not part of the study.

      In phase 1, up to six cohorts of at least 6 patients each will be treated with the study
      therapy, with lenalidomide in increasing dosages, to determine the maximum tolerated dose
      (MTD).

      In phase 2, 50 patients will be treated with the MTD. Efficacy and safety will be evaluated.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Response Rate (ORR)
time frame: 78 - 85 days + 2 years Follow Up
description: The percentage of patients which showed either a partial remission (PR), a complete remission with remaining uncertainty (CRu) or a complete remission (CR) after study treatment.
measure: Maximum tolerated dose (MTD)
time frame: 78 - 85 days
description: The maximum dose of lenalidomide tolerated with acceptable toxicity during phase 1 of this study. The MTD established in phase 1 of this study will be administered to 50 patients in phase 2 of this study.
measure: Rate of complete remission
time frame: 78 - 85 days + 2 years Follow Up
description: laboratory, BM biopsy, imaging
measure: Rate of primary progression
time frame: 78 - 85 days + 2 years Follow Up
description: The rate of patients which show progressive disease (PD) during or directly after study therapy
measure: Rate of treatment related deaths
time frame: 78 - 85 days + 2 years Follow Up
description: check survival
measure: Relapse Rate
time frame: 78 - 85 days + 2 years Follow Up
description: laboratory, BM biopsy, imaging
measure: Overall Survival
time frame: 78 - 85 days + 2 years Follow Up
description: check survival
measure: Progression free survival
time frame: 78 - 85 days + 2 years Follow Up
description: laboratory, BM biopsy, imaging
measure: tumour control
time frame: 78 - 85 days + 2 years Follow Up
description: laboratory, BM biopsy
measure: feasibility of stem cell mobilization
time frame: 78 - 85 days + 2 years Follow Up
description: The collection of peripheral stem cells is needed to be able to offer the patient high dose chemotherapy followed by autologous stem cell transplantation after the study treatment has ended.
Stem cell collection of <2.0 *10e6 CD34+cells/kg will be considered insufficient.
measure: incidence of non-hematological toxicities > grade 2 CTC
time frame: 78 - 85 days + 2 years Follow Up
measure: incidence and duration of neutropenia and thrombopenia grade 4
time frame: 78 - 85 days + 2 years Follow Up
description: laboratory WBC < 1.0 /nl or Plt < 25 /nl
arm group label: R²-DHAP
arm group type: Experimental
description: Combination treatment with immunochemotherapy (R-DHAP) and lenalidomide
Dosage:
Rituximab 375 mg/m² day 1, i.v. Cisplatin 100 mg/m² or Carboplatin AUC5 day 2, i.v. Cytarabine 2000 mg/m², administered twice, on day 3, i.v. Dexamethasone 40 mg, days 2-5, p.o. Lenalidomide 5-20 mg, day 1-7 / day-6-+7, p.o. PEG-Filgrastim 6 mg, day 6, s.c.
peripheral stem cell collection after cycle 1 or 2
intervention type: Drug
intervention name: Rituximab
description: Rituximab 375 mg/m²
arm group label: R²-DHAP
other name: MabThera
intervention type: Drug
intervention name: Cisplatin
description: Cisplatinum 100 mg / m²
arm group label: R²-DHAP
other name: Cisplatinum
intervention type: Drug
intervention name: Carboplatin
description: Carboplatinum AUC5
arm group label: R²-DHAP
other name: Carboplatinum
intervention type: Drug
intervention name: Dexamethasone
description: Dexamethasone 40 mg
arm group label: R²-DHAP
intervention type: Drug
intervention name: Cytarabine
description: Cytarabine 2000 mg/m², administered twice
arm group label: R²-DHAP
other name: Cytarabin
other name: Ara-C
intervention type: Drug
intervention name: Lenalidomide
description: 5-20 mg administered either d1-d7, or d-6-d7
arm group label: R²-DHAP
other name: Revlimid
intervention type: Drug
intervention name: PegFilgrastim
description: PegFilgrastim 6 mg
arm group label: R²-DHAP
other name: Neulasta
intervention type: Procedure
intervention name: peripheral stem cell collection
description: collection of peripheral stem cells for autologous stem cell transplantation
arm group label: R²-DHAP
other name: peripheral stem cell apheresis
other name: hematopoetic stem cell apheresis
other name: peripheral hematopoetic stem cell apheresis
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Bertram Glaß, MD
role: Principal Investigator
affiliation: AK St.Georg
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country: Germany
url: http://www.lymphome.de/
description: Homepage of the "Kompetenznetz Maligne Lymphome"
responsible party type: Sponsor
mesh term: Burkitt Lymphoma
mesh term: Lymphoma
mesh term: Lymphoma, B-Cell
mesh term: Lymphoma, Mantle-Cell
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Aggression
mesh term: Cytarabine
mesh term: Dexamethasone
mesh term: Rituximab
mesh term: Carboplatin
mesh term: Lenalidomide