<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/NCT01702155</url>
  </required_header>
  <id_info>
    <org_study_id>D11-11002</org_study_id>
    <nct_id>NCT01702155</nct_id>
  </id_info>
  <brief_title>Phase I/II Study of DFP-10917 in Patients With Acute Leukemia</brief_title>
  <official_title>A Phase I/II Study of DFP 10917 Given by Continuous Infusion in Patients With Relapsed or Refractory Acute Leukemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Delta-Fly Pharma, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Delta-Fly Pharma, Inc.</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the safety and efficacy of DFP-10917 given via&#xD;
      continuous 7 or 14 day infusion to patients with acute leukemias (AML or ALL).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will determine the safety and efficacy of DFP-10917 in patients with AML or ALL.&#xD;
      The Phase I dose-escalation portion of the study will determine the highest tolerable dose&#xD;
      and regimen (7 or 14 day continuous infusion) based on safety data in patients with&#xD;
      refractory or relapsed AML or ALL. The phase II portion will investigate the safety and&#xD;
      efficacy of DFP-10917, at the dose and regimen to be determined in the Phase I portion, in&#xD;
      patients with refractory or relapsed AML.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 10, 2012</start_date>
  <completion_date type="Actual">October 11, 2017</completion_date>
  <primary_completion_date type="Actual">January 18, 2017</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>Number of patients with adverse events</measure>
    <time_frame>Up to 30 days after the last dose</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <condition>Acute Lymphocytic Leukemia</condition>
  <arm_group>
    <arm_group_label>DFP-10917</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>7-day continuous infusion (in the vein): Starting dose 4 mg/m^2&#xD;
14-day continuous infusion (in the vein): Starting dose 10 mg/m^2&#xD;
Phase II Only: 6 mg/m^2 for the 14-day continuous infusion (in the vein)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DFP-10917</intervention_name>
    <arm_group_label>DFP-10917</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients must have pathologically-confirmed acute leukemia, refractory or relapsed&#xD;
             after standard therapy for the disease or for which conventional systemic chemotherapy&#xD;
             is not reliably effective or no effective therapy is available Phase II Only: Patient&#xD;
             must have histologically or pathologically confirmed diagnosis of AML based on WHO&#xD;
             classification that is refractory after standard therapy, or for which conventional&#xD;
             systemic chemotherapy is not reliably effective, or no effective therapy is available.&#xD;
             Patients aged 60 years or older with newly diagnosed AML who are not eligible for, or&#xD;
             who refuse, standard care are also eligible.&#xD;
&#xD;
          2. Aged ≥ 18 years.&#xD;
&#xD;
          3. ECOG Performance Status of 0, 1 or 2.&#xD;
&#xD;
          4. Adequate clinical laboratory values (i.e., plasma creatinine &lt;= 1.5 x upper limit of&#xD;
             normal (ULN) for the institution, bilirubin &lt;=1.5 x ULN, alanine transaminase (ALT)&#xD;
             and aspartate transaminase (AST) &lt;= 2.5 x ULN).&#xD;
&#xD;
          5. Absence of CNS involvement by leukemia.&#xD;
&#xD;
          6. Absence of uncontrolled intercurrent illnesses, including uncontrolled infections,&#xD;
             cardiac conditions, or other organ dysfunctions.&#xD;
&#xD;
          7. Signed informed consent prior to the start of any study specific procedures.&#xD;
&#xD;
          8. Women of child-bearing potential must have a negative serum or urine pregnancy test.&#xD;
             Male and female patients must agree to use acceptable contraceptive methods for the&#xD;
             duration of the study and for at least one month after the last drug administration.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The interval from prior treatment to time of study drug administration is &lt; 2 weeks&#xD;
             for cytotoxic agents or &lt; 5 half-lives for noncytotoxic agents. Exceptions: Use of&#xD;
             hydroxyurea is allowed before the start of study and may be administered up to day 5&#xD;
             of the first cycle.&#xD;
&#xD;
          2. Any &gt;grade 1 persistent clinically significant toxicities from prior chemotherapy.&#xD;
&#xD;
          3. Extensive prior radiotherapy to more than 30% of bone marrow reserves, or prior bone&#xD;
             marrow/stem cell transplantation.&#xD;
&#xD;
          4. Any concomitant condition that in the opinion of the investigator could compromise the&#xD;
             objectives of this study and the patient's compliance.&#xD;
&#xD;
          5. A pregnant or lactating woman.&#xD;
&#xD;
          6. Current malignancies of another type. Exceptions: Patients may participate if they&#xD;
             have previously treated and currently controlled prostate cancer, adequately treated&#xD;
             in situ cervical cancer and basal cell skin cancer or other malignancies with no&#xD;
             evidence of disease for 2 years or more.&#xD;
&#xD;
          7. Patient has acute promyelocytic leukemia (APL).&#xD;
&#xD;
          8. Patients with known HIV, HBV or HCV infection (note: testing for these infections is&#xD;
             not required).&#xD;
&#xD;
          9. Documented or known clinically significant bleeding disorder.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/30668890</url>
    <description>Publication of Study Results</description>
  </link>
  <results_reference>
    <citation>Kantarjian HM, Jabbour EJ, Garcia-Manero G, Kadia TM, DiNardo CD, Daver NG, Borthakur G, Jain N, Waukau JB, Kwari MI, Ravandi F, Anderson BD, Iizuka K, Jin C, Zhang C, Plunkett WK. Phase 1/2 study of DFP-10917 administered by continuous intravenous infusion in patients with recurrent or refractory acute myeloid leukemia. Cancer. 2019 May 15;125(10):1665-1673. doi: 10.1002/cncr.31923. Epub 2019 Jan 22.</citation>
    <PMID>30668890</PMID>
  </results_reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>October 23, 2019</last_update_submitted>
  <last_update_submitted_qc>October 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-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/NCT01702155
org study id: D11-11002
nct id: NCT01702155
lead sponsor: 
The purpose of this study is to determine the safety and efficacy of DFP-10917 given via
      continuous 7 or 14 day infusion to patients with acute leukemias (AML or ALL).
This study will determine the safety and efficacy of DFP-10917 in patients with AML or ALL.
      The Phase I dose-escalation portion of the study will determine the highest tolerable dose
      and regimen (7 or 14 day continuous infusion) based on safety data in patients with
      refractory or relapsed AML or ALL. The phase II portion will investigate the safety and
      efficacy of DFP-10917, at the dose and regimen to be determined in the Phase I portion, in
      patients with refractory or relapsed AML.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients with adverse events
time frame: Up to 30 days after the last dose
arm group label: DFP-10917
arm group type: Experimental
description: 7-day continuous infusion (in the vein): Starting dose 4 mg/m^2
14-day continuous infusion (in the vein): Starting dose 10 mg/m^2
Phase II Only: 6 mg/m^2 for the 14-day continuous infusion (in the vein)
intervention type: Drug
intervention name: DFP-10917
arm group label: DFP-10917
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
url: https://www.ncbi.nlm.nih.gov/pubmed/30668890
description: Publication of Study Results
citation: Kantarjian HM, Jabbour EJ, Garcia-Manero G, Kadia TM, DiNardo CD, Daver NG, Borthakur G, Jain N, Waukau JB, Kwari MI, Ravandi F, Anderson BD, Iizuka K, Jin C, Zhang C, Plunkett WK. Phase 1/2 study of DFP-10917 administered by continuous intravenous infusion in patients with recurrent or refractory acute myeloid leukemia. Cancer. 2019 May 15;125(10):1665-1673. doi: 10.1002/cncr.31923. Epub 2019 Jan 22.
PMID: 30668890
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma