<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/NCT04425655</url>
  </required_header>
  <id_info>
    <org_study_id>UCHMC1914</org_study_id>
    <nct_id>NCT04425655</nct_id>
  </id_info>
  <brief_title>Fludarabine in Combination With Daunorubicin and Cytarabine Liposome in Newly-diagnosed Acute Myeloid Leukemia.</brief_title>
  <official_title>A Phase II Trial of Fludarabine in Combination With Daunorubicin and Cytarabine Liposome for Adults With Newly-diagnosed Acute Myeloid Leukemia: University of California Hematologic Malignancies Consortium Protocol 1914</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jazz Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Diego</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase 2 clinical trial will evaluate the effectiveness and safety of fludarabine in&#xD;
      combination with CPX-351 in patients with untreated AML. Patients will receive fludarabine&#xD;
      and CPX-351 during Induction 1 and 2 as well as 2 cycles of consolidation therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase 2, open label single arm study to look at the effectives and safety of&#xD;
      fludarabine in combination with CPX-351 in patients with untreated AML. The rationale for&#xD;
      this combination stems from data which indicated that pre-treatment of the THP-1 cell line&#xD;
      with fludarabine for 4 hours prior to CPX-351 administration (Flu-CPX) significantly&#xD;
      potentiated intracellular ara-CTP accumulation compared to CPX-351 alone. This suggests that&#xD;
      fludarabine combined with CPX-351 may have efficacy against leukemic clones that would be&#xD;
      resistant to CPX-351 or standard chemotherapy in first induction. It has been demonstrated&#xD;
      that treatment with CPX-351 produces superior clinical outcomes in secondary AML likely due&#xD;
      to its novel formulation, which results in sustained exposure of the cytotoxic agents&#xD;
      cytarabine and daunorubicin in a synergistic 5:1 ratio within the plasma and bone marrow.&#xD;
      Fludarabine can potentially improve upon the outcomes observed with CPX-351 monotherapy and&#xD;
      7+3 by enhancing intracellular ara-CTP accumulation from CPX-351. Patients will received&#xD;
      fludarabine and CPX-351 for up to 2 cycles of induction and 2 cycles of consolidation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Original investigator for the trial has left&#xD;
  </why_stopped>
  <start_date type="Actual">August 5, 2020</start_date>
  <completion_date type="Actual">July 1, 2022</completion_date>
  <primary_completion_date type="Actual">July 1, 2022</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 response rate after induction</measure>
    <time_frame>35 days</time_frame>
    <description>Overall response rate after induction, defined as the sum of complete response (CR) rate and complete response with incomplete count recovery (CRi) rate after 1-2 cycles of induction therapy, in accordance with 2017 ELN criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety and Tolerability</measure>
    <time_frame>6 months</time_frame>
    <description>Safety and tolerability will be determined by rates of NCI CTCAE 5.0 Grade 3-5 toxicities and rate of discontinuation from study therapy due to intolerance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Grade 3 Treatment Emergent Adverse Events [Safety and Tolerability]</measure>
    <time_frame>6 months</time_frame>
    <description>Safety and tolerability will be determined by rates of NCI CTCAE 5.0 Grade 3 toxicities and rate of discontinuation from study therapy due to intolerance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Grade 4 Treatment Emergent Adverse Events [Safety and Tolerability]</measure>
    <time_frame>6 months</time_frame>
    <description>Safety and tolerability will be determined by rates of NCI CTCAE 5.0 Grade 4 toxicities and rate of discontinuation from study therapy due to intolerance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Grade 5 Treatment Emergent Adverse Events [Safety and Tolerability]</measure>
    <time_frame>6 months</time_frame>
    <description>Safety and tolerability will be determined by rates of NCI CTCAE 5.0 Grade 5 toxicities and rate of discontinuation from study therapy due to intolerance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CR Rate</measure>
    <time_frame>60 days</time_frame>
    <description>CR rate defined as proportion of patients achieving a CR after 1-2 cycles of induction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response rate</measure>
    <time_frame>35 days</time_frame>
    <description>Overall response rate (CR +CRi) after 1 cycle of induction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>1 year</time_frame>
    <description>Overall survival (OS) at 1 year, with OS defined as time from start of study therapy to death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>3 years</time_frame>
    <description>Overall survival (OS) at 3 years, with OS defined as time from start of study therapy to death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leukemia-free survival</measure>
    <time_frame>1 years</time_frame>
    <description>Leukemia-free survival (LFS) at 1 year, with EFS defined as the time from start of study therapy until failure to attain CR, relapse, or death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leukemia-free survival</measure>
    <time_frame>3 years</time_frame>
    <description>Leukemia-free survival (LFS) at 3 years, with EFS defined as the time from start of study therapy until failure to attain CR, relapse, or death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event free survival</measure>
    <time_frame>1 year</time_frame>
    <description>Event Free Survival (EFS) at 1 year, with EFS defined as the time from start of study therapy until failure to attain CR, relapse, or death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event free survival</measure>
    <time_frame>3 years</time_frame>
    <description>Event Free Survival (EFS) at 3 years, with EFS defined as the time from start of study therapy until failure to attain CR, relapse, or death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Platelet Recovery</measure>
    <time_frame>60 days</time_frame>
    <description>Platelet recovery, defined as the time from start of study therapy until absolute neutrophil count &gt;1,000/mcl in patients achieving a CR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day</measure>
    <time_frame>30 days from start of study therapy</time_frame>
    <description>30-day mortality defined as death from any cause within 30 days of starting study therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>60-day mortality</measure>
    <time_frame>60 days from start of study therapy</time_frame>
    <description>60-day mortality defined as death from any cause within 60 days of starting study therapy</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Minimal Residual Disease (MRD) Response (positive or negative)</measure>
    <time_frame>60 days</time_frame>
    <description>MRD response at CR/CRi will be assessed by multiparameter flow cytometry at the University of Washington.</description>
  </other_outcome>
  <other_outcome>
    <measure>Descriptive Statistics of Patients Mutation Profile at Screening</measure>
    <time_frame>At Screening</time_frame>
    <description>Somatic mutation profile as determined by next generation sequencing will be performed for recurrent AML mutations using standard technique used at individual sites (local or send-out testing)</description>
  </other_outcome>
  <other_outcome>
    <measure>Descriptive Statistics of Patients Mutation Profile at Relapse</measure>
    <time_frame>At Relapse</time_frame>
    <description>Somatic mutation profile as determined by next generation sequencing will be performed for recurrent AML mutations using standard technique.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Acute Myeloid Leukemia, Adult</condition>
  <condition>AML</condition>
  <condition>AML, Adult</condition>
  <arm_group>
    <arm_group_label>Fludarabine and CPX351</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Induction 1:&#xD;
Fludarabine 30 mg/m2/day IV on days 1-5 for 5 doses Daunorubicin and cytarabine liposome (CPX-351) daunorubicin 44 mg/m2/day and cytarabine 100 mg/m2/day IV on days 1, 3, 5 (given 4 hours after fludarabine infusion) for 3 doses&#xD;
Induction 2 (residual leukemia after Induction 1):&#xD;
Fludarabine 30 mg/m2/day IV on days 1-3 for 3 doses&#xD;
Daunorubicin and cytarabine liposome (CPX-351) daunorubicin 44 mg/m2/day and cytarabine 100 mg/m2/day IV on days 1, 3 (given 4 hours after fludarabine infusion) for 2 doses&#xD;
Optional consolidation, up to 2 cycles:&#xD;
Daunorubicin and cytarabine liposome (CPX-351) daunorubicin 29 mg/m2/day and cytarabine 65 mg/m2/day IV on days 1, 3 for 2 doses</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fludarabine</intervention_name>
    <description>30mg/m2 days 1 through 5</description>
    <arm_group_label>Fludarabine and CPX351</arm_group_label>
    <other_name>Oforta, Fludara</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vyxeos</intervention_name>
    <description>100U/m2 days 1, 3 5 in induction, 65U/m2 days 1 and 3 for consolidation</description>
    <arm_group_label>Fludarabine and CPX351</arm_group_label>
    <other_name>CPX-351</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically confirmed de novo or secondary AML as defined by WHO criteria&#xD;
&#xD;
          2. Intermediate- or poor-risk disease by ELN 2017 criteria&#xD;
&#xD;
          3. Adults 18 years of age or older&#xD;
&#xD;
          4. ECOG performance status of 0, 1, or 2&#xD;
&#xD;
          5. Able to give informed consent and follow study guidelines&#xD;
&#xD;
          6. Organ function requirements:&#xD;
&#xD;
               1. Adequate renal function defined as creatinine clearance greater than 60 ml/min&#xD;
&#xD;
               2. Adequate hepatic function defined by serum bilirubin less than or equal 2 mg/dL.&#xD;
                  If serum bilirubin greater than 2 mg/dl and direct bilirubin is less than 30&#xD;
                  percent of total bilirubin contact study chair for eligibility exception for&#xD;
                  Gilbert's syndrome.&#xD;
&#xD;
               3. ALT/AST less than or equal to 3 times the upper limit of normal&#xD;
&#xD;
               4. LVEF 50 percent by echocardiogram or MUGA&#xD;
&#xD;
          7. Patients with history of second malignancies in complete remission and without history&#xD;
             of metastasis are eligible if there is clinical evidence of disease stability for a&#xD;
             period of greater than 6 months off cytotoxic chemotherapy, documented by imaging,&#xD;
             tumor marker studies, etc., at screening.&#xD;
&#xD;
          8. Women of child-bearing potential and men with partners of child-bearing potential must&#xD;
             agree to use adequate contraception (hormonal or barrier method of birth control;&#xD;
             abstinence) prior to study entry, for the duration of study participation, and for 120&#xD;
             days following completion of therapy. Should a woman become pregnant or suspect she is&#xD;
             pregnant while participating in this study, she should inform her treating physician&#xD;
             immediately.&#xD;
&#xD;
          9. Women of child-bearing potential has negative pregnancy test prior to initiating study&#xD;
             drug dosing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current or anticipated use of additional investigational agents.&#xD;
&#xD;
          2. Any prior treatment for AML with the exception of corticosteroids, hydroxyurea, and/or&#xD;
             leukapheresis to prevent or treat early complications prior to starting study therapy.&#xD;
             Permitted prior therapy must be stopped 24 hours prior to starting study therapy.&#xD;
&#xD;
          3. Prior use of hypomethylating agents is permitted for patients with history of&#xD;
             antecedent MDS. Last dose of hypomethylating therapy must have been 15 or more days&#xD;
             prior to starting study therapy. Toxicities associated with prior MDS therapy must&#xD;
             have recovered to grade 1 or less prior to start of treatment.&#xD;
&#xD;
          4. Favorable risk cytogenetics as defined by 2017 ELN risk stratification including acute&#xD;
             promyelocytic leukemia&#xD;
&#xD;
          5. Chronic myeloid leukemia in myeloid blast crisis&#xD;
&#xD;
          6. Except for CMML, patients with history of myeloproliferative neoplasms (MPN) (defined&#xD;
             as a history of essential thrombocytosis or polycythemia vera, or idiopathic&#xD;
             myelofibrosis prior to the diagnosis of AML) or combined MDS/MPN are not eligible&#xD;
&#xD;
          7. Clinical evidence of active CNS leukemia&#xD;
&#xD;
          8. Active or metastatic second malignancy&#xD;
&#xD;
          9. Any major surgery or radiation therapy within four weeks.&#xD;
&#xD;
         10. Patients with prior cumulative anthracycline exposure of greater than 368 mg/m2&#xD;
             daunorubicin (or equivalent).&#xD;
&#xD;
         11. Any serious medical condition, laboratory abnormality or psychiatric illness that&#xD;
             would prevent obtaining informed consent&#xD;
&#xD;
         12. Patients with myocardial impairment of any cause (e.g. cardiomyopathy, ischemic heart&#xD;
             disease, significant valvular dysfunction, hypertensive heart disease, and congestive&#xD;
             heart failure) resulting in heart failure by New York Heart Association Criteria&#xD;
             (Class III or IV staging)&#xD;
&#xD;
         13. Active or uncontrolled infection. Patients with an infection receiving treatment&#xD;
             (antibiotic, antifungal or antiviral treatment) may be entered into the study but must&#xD;
             be afebrile and hemodynamically stable for greater than or equal to 72 hrs.&#xD;
&#xD;
         14. Current evidence of invasive fungal infection (blood or tissue culture); patients with&#xD;
             recent fungal infection must have subsequent negative culture(s) to be eligible&#xD;
&#xD;
         15. Known HIV infection&#xD;
&#xD;
         16. Active hepatitis B or hepatitis C infection&#xD;
&#xD;
         17. Hypersensitivity to cytarabine, daunorubicin or liposomal products&#xD;
&#xD;
         18. History of Wilson's disease or copper-metabolism disorder&#xD;
&#xD;
         19. Pregnant or breastfeeding&#xD;
&#xD;
         20. Any condition which in the opinion of the investigator will interfere with the ability&#xD;
             of the subject to comply with the requirements of the study&#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>Matthew Wieduwilt, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>UC San Diego</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCSD Moores Cancer Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>September 19, 2022</last_update_submitted>
  <last_update_submitted_qc>September 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>James Mangan</investigator_full_name>
    <investigator_title>Associate Clinical Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Vyxeos</keyword>
  <keyword>CPX-351</keyword>
  <keyword>Fludarabine</keyword>
  <keyword>Untreated AML</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fludarabine</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>June 30, 2023</submitted>
    <returned>July 24, 2023</returned>
  </pending_results>
  <!-- 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/NCT04425655
org study id: UCHMC1914
nct id: NCT04425655
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This phase 2 clinical trial will evaluate the effectiveness and safety of fludarabine in
      combination with CPX-351 in patients with untreated AML. Patients will receive fludarabine
      and CPX-351 during Induction 1 and 2 as well as 2 cycles of consolidation therapy.
This is a phase 2, open label single arm study to look at the effectives and safety of
      fludarabine in combination with CPX-351 in patients with untreated AML. The rationale for
      this combination stems from data which indicated that pre-treatment of the THP-1 cell line
      with fludarabine for 4 hours prior to CPX-351 administration (Flu-CPX) significantly
      potentiated intracellular ara-CTP accumulation compared to CPX-351 alone. This suggests that
      fludarabine combined with CPX-351 may have efficacy against leukemic clones that would be
      resistant to CPX-351 or standard chemotherapy in first induction. It has been demonstrated
      that treatment with CPX-351 produces superior clinical outcomes in secondary AML likely due
      to its novel formulation, which results in sustained exposure of the cytotoxic agents
      cytarabine and daunorubicin in a synergistic 5:1 ratio within the plasma and bone marrow.
      Fludarabine can potentially improve upon the outcomes observed with CPX-351 monotherapy and
      7+3 by enhancing intracellular ara-CTP accumulation from CPX-351. Patients will received
      fludarabine and CPX-351 for up to 2 cycles of induction and 2 cycles of consolidation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall response rate after induction
time frame: 35 days
description: Overall response rate after induction, defined as the sum of complete response (CR) rate and complete response with incomplete count recovery (CRi) rate after 1-2 cycles of induction therapy, in accordance with 2017 ELN criteria.
measure: Safety and Tolerability
time frame: 6 months
description: Safety and tolerability will be determined by rates of NCI CTCAE 5.0 Grade 3-5 toxicities and rate of discontinuation from study therapy due to intolerance
measure: Incidence of Grade 3 Treatment Emergent Adverse Events [Safety and Tolerability]
time frame: 6 months
description: Safety and tolerability will be determined by rates of NCI CTCAE 5.0 Grade 3 toxicities and rate of discontinuation from study therapy due to intolerance
measure: Incidence of Grade 4 Treatment Emergent Adverse Events [Safety and Tolerability]
time frame: 6 months
description: Safety and tolerability will be determined by rates of NCI CTCAE 5.0 Grade 4 toxicities and rate of discontinuation from study therapy due to intolerance
measure: Incidence of Grade 5 Treatment Emergent Adverse Events [Safety and Tolerability]
time frame: 6 months
description: Safety and tolerability will be determined by rates of NCI CTCAE 5.0 Grade 5 toxicities and rate of discontinuation from study therapy due to intolerance
measure: CR Rate
time frame: 60 days
description: CR rate defined as proportion of patients achieving a CR after 1-2 cycles of induction
measure: Overall response rate
time frame: 35 days
description: Overall response rate (CR +CRi) after 1 cycle of induction
measure: Overall survival
time frame: 1 year
description: Overall survival (OS) at 1 year, with OS defined as time from start of study therapy to death from any cause
measure: Overall survival
time frame: 3 years
description: Overall survival (OS) at 3 years, with OS defined as time from start of study therapy to death from any cause
measure: Leukemia-free survival
time frame: 1 years
description: Leukemia-free survival (LFS) at 1 year, with EFS defined as the time from start of study therapy until failure to attain CR, relapse, or death from any cause
measure: Leukemia-free survival
time frame: 3 years
description: Leukemia-free survival (LFS) at 3 years, with EFS defined as the time from start of study therapy until failure to attain CR, relapse, or death from any cause
measure: Event free survival
time frame: 1 year
description: Event Free Survival (EFS) at 1 year, with EFS defined as the time from start of study therapy until failure to attain CR, relapse, or death from any cause.
measure: Event free survival
time frame: 3 years
description: Event Free Survival (EFS) at 3 years, with EFS defined as the time from start of study therapy until failure to attain CR, relapse, or death from any cause.
measure: Platelet Recovery
time frame: 60 days
description: Platelet recovery, defined as the time from start of study therapy until absolute neutrophil count >1,000/mcl in patients achieving a CR
measure: 30-day
time frame: 30 days from start of study therapy
description: 30-day mortality defined as death from any cause within 30 days of starting study therapy
measure: 60-day mortality
time frame: 60 days from start of study therapy
description: 60-day mortality defined as death from any cause within 60 days of starting study therapy
measure: Minimal Residual Disease (MRD) Response (positive or negative)
time frame: 60 days
description: MRD response at CR/CRi will be assessed by multiparameter flow cytometry at the University of Washington.
measure: Descriptive Statistics of Patients Mutation Profile at Screening
time frame: At Screening
description: Somatic mutation profile as determined by next generation sequencing will be performed for recurrent AML mutations using standard technique used at individual sites (local or send-out testing)
measure: Descriptive Statistics of Patients Mutation Profile at Relapse
time frame: At Relapse
description: Somatic mutation profile as determined by next generation sequencing will be performed for recurrent AML mutations using standard technique.
arm group label: Fludarabine and CPX351
arm group type: Experimental
description: Induction 1:
Fludarabine 30 mg/m2/day IV on days 1-5 for 5 doses Daunorubicin and cytarabine liposome (CPX-351) daunorubicin 44 mg/m2/day and cytarabine 100 mg/m2/day IV on days 1, 3, 5 (given 4 hours after fludarabine infusion) for 3 doses
Induction 2 (residual leukemia after Induction 1):
Fludarabine 30 mg/m2/day IV on days 1-3 for 3 doses
Daunorubicin and cytarabine liposome (CPX-351) daunorubicin 44 mg/m2/day and cytarabine 100 mg/m2/day IV on days 1, 3 (given 4 hours after fludarabine infusion) for 2 doses
Optional consolidation, up to 2 cycles:
Daunorubicin and cytarabine liposome (CPX-351) daunorubicin 29 mg/m2/day and cytarabine 65 mg/m2/day IV on days 1, 3 for 2 doses
intervention type: Drug
intervention name: Fludarabine
description: 30mg/m2 days 1 through 5
arm group label: Fludarabine and CPX351
other name: Oforta, Fludara
intervention type: Drug
intervention name: Vyxeos
description: 100U/m2 days 1, 3 5 in induction, 65U/m2 days 1 and 3 for consolidation
arm group label: Fludarabine and CPX351
other name: CPX-351
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthew Wieduwilt, MD, PhD
role: Study Chair
affiliation: UC San Diego
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: James Mangan
investigator title: Associate Clinical Professor of Medicine
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Fludarabine
submitted: June 30, 2023
returned: July 24, 2023