<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/NCT04423926</url>
  </required_header>
  <id_info>
    <org_study_id>2019-SR-429</org_study_id>
    <nct_id>NCT04423926</nct_id>
  </id_info>
  <brief_title>Lenalidomide in Combination With CHOP in Patients With Untreated PTCL</brief_title>
  <official_title>A Phase II, Prospective, Single-center Study of Lenalidomide in Combination With CHOP in Patients With Untreated PTCL</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital with Nanjing Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The prognosis of PTCL (except early stage ALK+ ALCL) is dismal. Previous study showed that&#xD;
      single agent lenalidomide showed promising therapeutic activity in patients with relapsed or&#xD;
      refractory PTCL. The investigators therefore design this phase II study to investigate the&#xD;
      safety and efficacy of lenalidomide in combination with CHOP in patients with treatment-naive&#xD;
      PTCL.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Anticipated">June 10, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>maximum tolerated dose and dose limited toxicity</measure>
    <time_frame>At the end of the first cycle of lenalidomide+CHOP (each cycle is 21 days)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall response rate</measure>
    <time_frame>6 months</time_frame>
    <description>overall response rate after treated by lenalidomide-CHOP regimen</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progressive free survival</measure>
    <time_frame>2 years</time_frame>
    <description>from date of inclusion to date of progression, relapse, or death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>2 years</time_frame>
    <description>from the date of inclusion to date of death, irrespective of cause</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">91</enrollment>
  <condition>PTCL, NOS</condition>
  <condition>AITL</condition>
  <condition>ALK- ALCL</condition>
  <condition>Phase III-IV ALK+ ALCL</condition>
  <condition>EATL</condition>
  <arm_group>
    <arm_group_label>Lenalidomide+CHOP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lenalidomide</intervention_name>
    <description>Lenalidomide 10mg/d#15mg/d#20mg/d#25mg/d d1~d10# 21days a cycle</description>
    <arm_group_label>Lenalidomide+CHOP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>Cyclophosphamide 750 mg/m2 d1</description>
    <arm_group_label>Lenalidomide+CHOP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doxorubicin</intervention_name>
    <description>Doxorubicin 50 mg/m2 d1</description>
    <arm_group_label>Lenalidomide+CHOP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vincristine</intervention_name>
    <description>Vincristine 1.4mg/m2 (maximum 2mg) d1</description>
    <arm_group_label>Lenalidomide+CHOP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisolone</intervention_name>
    <description>Prednisolone 60mg/m2 d1-5</description>
    <arm_group_label>Lenalidomide+CHOP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically confirmed PTCL, NOS, AITL, ALK- ALCL, phase III-IV ALK+ ALCL, EATL&#xD;
             according to WHO 2016 criteria.&#xD;
&#xD;
          2. ECOG PS 0-2&#xD;
&#xD;
          3. Age 18-70 years old&#xD;
&#xD;
          4. Expected survival ≥ 12 weeks&#xD;
&#xD;
          5. A measurable or evaluable disease at the time of enrolment (diameter ≥1.5cm)&#xD;
&#xD;
          6. Understand and voluntarily sign an informed consent form, able to adhere to the study&#xD;
             visit schedule and other protocol requirements.&#xD;
&#xD;
          7. Female subjects in childbearing age, their serum or urine pregnancy test must be&#xD;
             negative. All patients must agree to take effective contraceptive measures during the&#xD;
             trial measures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women who are pregnant or lactating. Patients have breeding intent in 12 months or&#xD;
             cannot take effective contraceptive measures during the trial measures&#xD;
&#xD;
          2. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital&#xD;
             immune deficiency diseases, including but not limited to HIV infected persons&#xD;
&#xD;
          3. Patients known to have varicella or herpes zoster virus infection&#xD;
&#xD;
          4. Previous exposure to any anti-tumor therapy&#xD;
&#xD;
          5. Poor hepatic and/or renal function, defined as total bilirubin, ALT, AST, Cr more than&#xD;
             two fold of upper normal level,Ccr# 50 mL/min unless these abnormalities were related&#xD;
             to the lymphoma&#xD;
&#xD;
          6. History of DVT or PE within past 12 months&#xD;
&#xD;
          7. Poor bone-marrow reserve, defined as neutrophil count less than 1.5×109/L or platelet&#xD;
             count less than 75×109/L, unless caused by bone marrow infiltration&#xD;
&#xD;
          8. New York Heart Association class III or IV cardiac failure; or Ejection fraction less&#xD;
             than 50%;or history of following disease in past 6 months: acute coronary&#xD;
             syndrome#acute heart failure#severe ventricular arrhythmia&#xD;
&#xD;
          9. CNS or meningeal involvement&#xD;
&#xD;
         10. Known sensitivity or allergy to investigational product&#xD;
&#xD;
         11. Major surgery within three weeks&#xD;
&#xD;
         12. Patients receiving organ transplantation&#xD;
&#xD;
         13. Patients with secondary tumour, excluding cured (5 years without relapse) in situ&#xD;
             Non-melanoma skin cancer. superficial bladder cancer, in situ cervical cancer,&#xD;
             Gastrointestinal intramucous carcinoma and breast cancer&#xD;
&#xD;
         14. Presence of Grade III nervous toxicity within past two weeks&#xD;
&#xD;
         15. Active and severe infectious diseases&#xD;
&#xD;
         16. Any potential drug abuse, medical, psychological or social conditions whichmay disturb&#xD;
             this investigation and assessment&#xD;
&#xD;
         17. In any conditions which investigator considered ineligible for this study.&#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>Wei Xu, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Li Wang, M.D., Ph.D.</last_name>
    <phone>86 25 68306034</phone>
    <email>lilyw7878@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wei Xu, M.D., Ph.D.</last_name>
    <phone>86 25 68306034</phone>
    <email>xuwei10000@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Li Wang, M.D., Ph.D</last_name>
      <phone>86 25 68306034</phone>
      <email>lilyw7878@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Wei Xu, M.D., Ph.D</last_name>
      <phone>86 25 68306034</phone>
      <email>xuwei10000@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Hopfinger G, Nosslinger T, Lang A, Linkesch W, Melchardt T, Weiss L, Egle A, Greil R. Lenalidomide in combination with vorinostat and dexamethasone for the treatment of relapsed/refractory peripheral T cell lymphoma (PTCL): report of a phase I/II trial. Ann Hematol. 2014 Mar;93(3):459-62. doi: 10.1007/s00277-014-2009-0. Epub 2014 Jan 18.</citation>
    <PMID>24441915</PMID>
  </reference>
  <reference>
    <citation>Morschhauser F, Fitoussi O, Haioun C, Thieblemont C, Quach H, Delarue R, Glaisner S, Gabarre J, Bosly A, Lister J, Li J, Coiffier B. A phase 2, multicentre, single-arm, open-label study to evaluate the safety and efficacy of single-agent lenalidomide (Revlimid) in subjects with relapsed or refractory peripheral T-cell non-Hodgkin lymphoma: the EXPECT trial. Eur J Cancer. 2013 Sep;49(13):2869-76. doi: 10.1016/j.ejca.2013.04.029. Epub 2013 May 31.</citation>
    <PMID>23731832</PMID>
  </reference>
  <reference>
    <citation>Iqbal J, Wright G, Wang C, Rosenwald A, Gascoyne RD, Weisenburger DD, Greiner TC, Smith L, Guo S, Wilcox RA, Teh BT, Lim ST, Tan SY, Rimsza LM, Jaffe ES, Campo E, Martinez A, Delabie J, Braziel RM, Cook JR, Tubbs RR, Ott G, Geissinger E, Gaulard P, Piccaluga PP, Pileri SA, Au WY, Nakamura S, Seto M, Berger F, de Leval L, Connors JM, Armitage J, Vose J, Chan WC, Staudt LM; Lymphoma Leukemia Molecular Profiling Project and the International Peripheral T-cell Lymphoma Project. Gene expression signatures delineate biological and prognostic subgroups in peripheral T-cell lymphoma. Blood. 2014 May 8;123(19):2915-23. doi: 10.1182/blood-2013-11-536359. Epub 2014 Mar 14.</citation>
    <PMID>24632715</PMID>
  </reference>
  <reference>
    <citation>Schmitz N, de Leval L. How I manage peripheral T-cell lymphoma, not otherwise specified and angioimmunoblastic T-cell lymphoma: current practice and a glimpse into the future. Br J Haematol. 2017 Mar;176(6):851-866. doi: 10.1111/bjh.14473. Epub 2016 Dec 16.</citation>
    <PMID>27982416</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 13, 2020</last_update_submitted>
  <last_update_submitted_qc>June 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Affiliated Hospital with Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>WEI XU</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>PTCL</keyword>
  <keyword>lenalidomide</keyword>
  <keyword>untreated</keyword>
  <keyword>CHOP</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma, Large-Cell, Anaplastic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Doxorubicin</mesh_term>
    <mesh_term>Vincristine</mesh_term>
    <mesh_term>Lenalidomide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04423926
org study id: 2019-SR-429
nct id: NCT04423926
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The prognosis of PTCL (except early stage ALK+ ALCL) is dismal. Previous study showed that
      single agent lenalidomide showed promising therapeutic activity in patients with relapsed or
      refractory PTCL. The investigators therefore design this phase II study to investigate the
      safety and efficacy of lenalidomide in combination with CHOP in patients with treatment-naive
      PTCL.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: maximum tolerated dose and dose limited toxicity
time frame: At the end of the first cycle of lenalidomide+CHOP (each cycle is 21 days)
measure: Overall response rate
time frame: 6 months
description: overall response rate after treated by lenalidomide-CHOP regimen
measure: Progressive free survival
time frame: 2 years
description: from date of inclusion to date of progression, relapse, or death from any cause
measure: Overall survival
time frame: 2 years
description: from the date of inclusion to date of death, irrespective of cause
arm group label: Lenalidomide+CHOP
arm group type: Experimental
intervention type: Drug
intervention name: Lenalidomide
description: Lenalidomide 10mg/d#15mg/d#20mg/d#25mg/d d1~d10# 21days a cycle
arm group label: Lenalidomide+CHOP
intervention type: Drug
intervention name: Cyclophosphamide
description: Cyclophosphamide 750 mg/m2 d1
arm group label: Lenalidomide+CHOP
intervention type: Drug
intervention name: Doxorubicin
description: Doxorubicin 50 mg/m2 d1
arm group label: Lenalidomide+CHOP
intervention type: Drug
intervention name: Vincristine
description: Vincristine 1.4mg/m2 (maximum 2mg) d1
arm group label: Lenalidomide+CHOP
intervention type: Drug
intervention name: Prednisolone
description: Prednisolone 60mg/m2 d1-5
arm group label: Lenalidomide+CHOP
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Wei Xu, M.D., Ph.D.
role: Principal Investigator
affiliation: The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
last name: Li Wang, M.D., Ph.D.
phone: 86 25 68306034
email: lilyw7878@163.com
last name: Wei Xu, M.D., Ph.D.
phone: 86 25 68306034
email: xuwei10000@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
citation: Hopfinger G, Nosslinger T, Lang A, Linkesch W, Melchardt T, Weiss L, Egle A, Greil R. Lenalidomide in combination with vorinostat and dexamethasone for the treatment of relapsed/refractory peripheral T cell lymphoma (PTCL): report of a phase I/II trial. Ann Hematol. 2014 Mar;93(3):459-62. doi: 10.1007/s00277-014-2009-0. Epub 2014 Jan 18.
PMID: 24441915
citation: Morschhauser F, Fitoussi O, Haioun C, Thieblemont C, Quach H, Delarue R, Glaisner S, Gabarre J, Bosly A, Lister J, Li J, Coiffier B. A phase 2, multicentre, single-arm, open-label study to evaluate the safety and efficacy of single-agent lenalidomide (Revlimid) in subjects with relapsed or refractory peripheral T-cell non-Hodgkin lymphoma: the EXPECT trial. Eur J Cancer. 2013 Sep;49(13):2869-76. doi: 10.1016/j.ejca.2013.04.029. Epub 2013 May 31.
PMID: 23731832
citation: Iqbal J, Wright G, Wang C, Rosenwald A, Gascoyne RD, Weisenburger DD, Greiner TC, Smith L, Guo S, Wilcox RA, Teh BT, Lim ST, Tan SY, Rimsza LM, Jaffe ES, Campo E, Martinez A, Delabie J, Braziel RM, Cook JR, Tubbs RR, Ott G, Geissinger E, Gaulard P, Piccaluga PP, Pileri SA, Au WY, Nakamura S, Seto M, Berger F, de Leval L, Connors JM, Armitage J, Vose J, Chan WC, Staudt LM; Lymphoma Leukemia Molecular Profiling Project and the International Peripheral T-cell Lymphoma Project. Gene expression signatures delineate biological and prognostic subgroups in peripheral T-cell lymphoma. Blood. 2014 May 8;123(19):2915-23. doi: 10.1182/blood-2013-11-536359. Epub 2014 Mar 14.
PMID: 24632715
citation: Schmitz N, de Leval L. How I manage peripheral T-cell lymphoma, not otherwise specified and angioimmunoblastic T-cell lymphoma: current practice and a glimpse into the future. Br J Haematol. 2017 Mar;176(6):851-866. doi: 10.1111/bjh.14473. Epub 2016 Dec 16.
PMID: 27982416
responsible party type: Principal Investigator
investigator affiliation: The First Affiliated Hospital with Nanjing Medical University
investigator full name: WEI XU
investigator title: Professor
mesh term: Lymphoma, Large-Cell, Anaplastic
mesh term: Prednisolone
mesh term: Cyclophosphamide
mesh term: Doxorubicin
mesh term: Vincristine
mesh term: Lenalidomide
sharing ipd: Undecided