<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/NCT03244930</url>
  </required_header>
  <id_info>
    <org_study_id>HE17-00007</org_study_id>
    <nct_id>NCT03244930</nct_id>
  </id_info>
  <brief_title>Low Dose Plerixafor Plus G-CSF in Mobilizing Stem Cells for Autologous Peripheral Blood Transplantation</brief_title>
  <official_title>Low Dose Plerixafor Plus G-CSF Efficiency in Mobilizing Stem Cells From Lymphoma and Myeloma Patients for Autologous Peripheral Blood Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario Dr. Jose E. Gonzalez</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitario Dr. Jose E. Gonzalez</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Plerixafor, is added to mobilizing chemotherapy and G-CSF to overcome poor stem cell&#xD;
      mobilization. We want to demonstrate that half of the commonly prescribed dose can be safely&#xD;
      administered once as a single dose in first attempt leading to apheresis yields of &gt;2 x 106&#xD;
      CD34+ cells/kg body weight.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Plerixafor, is added to mobilizing chemotherapy and G-CSF to overcome poor stem cell&#xD;
      mobilization. Consecutive patients in autologous transplant protocol will receive&#xD;
      mobilization consisted of daily subcutaneously G-CSF 10 mg/kg for 4 days and plerixafor 0.12&#xD;
      mg/kg as a single dose 11 hours prior to initiation of apheresis. HSC collection was&#xD;
      performed with a Cobe Spectra® or Spectra Optia® apheresis system. The planned target blood&#xD;
      volume to be processed will be 4-fold total blood volume calculated according to patients'&#xD;
      weight and size. Peripheral blood CD34+ counts will be analyzed using flow cytometry. For&#xD;
      each ASCT, we aimed for target yields of at least 2 x 106 CD34+cells/kg. Toxicities and&#xD;
      engraftment will be documented.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 10, 2017</start_date>
  <completion_date type="Anticipated">June 10, 2018</completion_date>
  <primary_completion_date type="Anticipated">May 10, 2018</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>
    <intervention_model_description>Prospective, open-labeled, single-arm study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Harvest of of at least 2 x106 CD34+/kg</measure>
    <time_frame>5 days</time_frame>
    <description>percentage of patients with a target yields of at least 2 x 106 CD34+ cells/kg in one single aphaeresis procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to engraftment</measure>
    <time_frame>100 days</time_frame>
    <description>Engraftment defined as 3 consecutive days of neutrophil counts higher than 0.5 x 103/mcl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients reaching a peripheral blood precount higher than 20 cells/μL</measure>
    <time_frame>5 days</time_frame>
    <description>Rate of patients reaching a peripheral blood precount higher than 20 cells/μL</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Lymphoma, Non-Hodgkin</condition>
  <condition>Lymphoma, Hodgkin</condition>
  <condition>Myeloma</condition>
  <condition>Stem Cell Transplant Complications</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Plerixafor 0.12 mg/kg SC will be administered in the evening, 11 hours prior to initiation of apheresis. G-CSF will be administered in the morning at 10 mcg/kg SC for 4 days prior to apheresis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Plerixafor 0.12 mg/kg</intervention_name>
    <description>Subcutaneously G-CSF 10 mg/kg for 4 days. At day four SC plerixafor 0.12 mg/kg as a single dose 11 hours prior to initiation of aphaeresis.</description>
    <arm_group_label>Arm 1</arm_group_label>
    <other_name>mozobil</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Candidates planned for an autologous haematopoietic stem cell transplantation without&#xD;
             previous mobilization attempts with chemotherapy.&#xD;
&#xD;
          2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.&#xD;
&#xD;
          3. WBC count ≥2.5x109/L.&#xD;
&#xD;
          4. Absolute neutrophil count ≥1.5x109/L.&#xD;
&#xD;
          5. Platelet count ≥100x109/L&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior allogeneic or autologous transplantation.&#xD;
&#xD;
          2. Pregnant women.&#xD;
&#xD;
          3. Acute infection (febrile, i.e. temperature &gt; 38C) within 24 hours prior to dosing or&#xD;
             antibiotic therapy within 7 days prior to the first dose of GCSF.&#xD;
&#xD;
          4. Positive serology for hepatitis B or C or HIV.&#xD;
&#xD;
          5. Left ventricular ejection fraction &lt; 40%&#xD;
&#xD;
          6. AST ALT &gt;2.5x or Creatinine &gt;2 md/dL&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Gomez Almaguer, md</last_name>
    <role>Study Director</role>
    <affiliation>Servicio de Hematología Hospital Universitario &quot;Dr. José Eleuterio Gonzalez&quot;</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Perla Colunga, MD</last_name>
    <phone>+528110761973</phone>
    <email>alrep_rcp@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dalila Alvarado, MD</last_name>
    <email>dalila_alvarado@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Servicio de Hematología Hospital Universitario &quot;Dr. José Eleuterio Gonzalez&quot;, Universidad Autónoma de Nuevo Leon</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo Leon</state>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Perla Colunga Pedraza, MD</last_name>
      <phone>+528110761973</phone>
      <email>colunga.perla@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Guillermo Sotomayor Duque, MD</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <results_reference>
    <citation>DiPersio JF, Micallef IN, Stiff PJ, Bolwell BJ, Maziarz RT, Jacobsen E, Nademanee A, McCarty J, Bridger G, Calandra G; 3101 Investigators. Phase III prospective randomized double-blind placebo-controlled trial of plerixafor plus granulocyte colony-stimulating factor compared with placebo plus granulocyte colony-stimulating factor for autologous stem-cell mobilization and transplantation for patients with non-Hodgkin's lymphoma. J Clin Oncol. 2009 Oct 1;27(28):4767-73. doi: 10.1200/JCO.2008.20.7209. Epub 2009 Aug 31.</citation>
    <PMID>19720922</PMID>
  </results_reference>
  <results_reference>
    <citation>Flomenberg N, Comenzo RL, Badel K, Calandra G. Plerixafor (Mozobil) alone to mobilize hematopoietic stem cells from multiple myeloma patients for autologous transplantation. Biol Blood Marrow Transplant. 2010 May;16(5):695-700. doi: 10.1016/j.bbmt.2009.12.538. Epub 2010 Jan 11.</citation>
    <PMID>20067838</PMID>
  </results_reference>
  <results_reference>
    <citation>Brave M, Farrell A, Ching Lin S, Ocheltree T, Pope Miksinski S, Lee SL, Saber H, Fourie J, Tornoe C, Booth B, Yuan W, He K, Justice R, Pazdur R. FDA review summary: Mozobil in combination with granulocyte colony-stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation. Oncology. 2010;78(3-4):282-8. doi: 10.1159/000315736. Epub 2010 Jun 8.</citation>
    <PMID>20530974</PMID>
  </results_reference>
  <results_reference>
    <citation>Haverkos BM, Huang Y, Elder P, O'Donnell L, Scholl D, Whittaker B, Vasu S, Penza S, Andritsos LA, Devine SM, Jaglowski SM. A single center's experience using four different front line mobilization strategies in lymphoma patients planned to undergo autologous hematopoietic cell transplantation. Bone Marrow Transplant. 2017 Apr;52(4):561-566. doi: 10.1038/bmt.2016.304. Epub 2017 Jan 9.</citation>
    <PMID>28067870</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>August 9, 2017</last_update_submitted>
  <last_update_submitted_qc>August 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitario Dr. Jose E. Gonzalez</investigator_affiliation>
    <investigator_full_name>David Gomez Almaguer</investigator_full_name>
    <investigator_title>Hematology division chief</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    <mesh_term>Hodgkin Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Plerixafor</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/NCT03244930
org study id: HE17-00007
nct id: NCT03244930
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Plerixafor, is added to mobilizing chemotherapy and G-CSF to overcome poor stem cell
      mobilization. We want to demonstrate that half of the commonly prescribed dose can be safely
      administered once as a single dose in first attempt leading to apheresis yields of >2 x 106
      CD34+ cells/kg body weight.
Plerixafor, is added to mobilizing chemotherapy and G-CSF to overcome poor stem cell
      mobilization. Consecutive patients in autologous transplant protocol will receive
      mobilization consisted of daily subcutaneously G-CSF 10 mg/kg for 4 days and plerixafor 0.12
      mg/kg as a single dose 11 hours prior to initiation of apheresis. HSC collection was
      performed with a Cobe Spectra® or Spectra Optia® apheresis system. The planned target blood
      volume to be processed will be 4-fold total blood volume calculated according to patients'
      weight and size. Peripheral blood CD34+ counts will be analyzed using flow cytometry. For
      each ASCT, we aimed for target yields of at least 2 x 106 CD34+cells/kg. Toxicities and
      engraftment will be documented.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective, open-labeled, single-arm study
primary purpose: Treatment
masking: None (Open Label)
measure: Harvest of of at least 2 x106 CD34+/kg
time frame: 5 days
description: percentage of patients with a target yields of at least 2 x 106 CD34+ cells/kg in one single aphaeresis procedure.
measure: Time to engraftment
time frame: 100 days
description: Engraftment defined as 3 consecutive days of neutrophil counts higher than 0.5 x 103/mcl
measure: Rate of patients reaching a peripheral blood precount higher than 20 cells/μL
time frame: 5 days
description: Rate of patients reaching a peripheral blood precount higher than 20 cells/μL
arm group label: Arm 1
arm group type: Experimental
description: Plerixafor 0.12 mg/kg SC will be administered in the evening, 11 hours prior to initiation of apheresis. G-CSF will be administered in the morning at 10 mcg/kg SC for 4 days prior to apheresis.
intervention type: Drug
intervention name: Plerixafor 0.12 mg/kg
description: Subcutaneously G-CSF 10 mg/kg for 4 days. At day four SC plerixafor 0.12 mg/kg as a single dose 11 hours prior to initiation of aphaeresis.
arm group label: Arm 1
other name: mozobil
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: David Gomez Almaguer, md
role: Study Director
affiliation: Servicio de Hematología Hospital Universitario "Dr. José Eleuterio Gonzalez"
last name: Perla Colunga, MD
phone: +528110761973
email: alrep_rcp@hotmail.com
last name: Dalila Alvarado, MD
email: dalila_alvarado@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Mexico
citation: DiPersio JF, Micallef IN, Stiff PJ, Bolwell BJ, Maziarz RT, Jacobsen E, Nademanee A, McCarty J, Bridger G, Calandra G; 3101 Investigators. Phase III prospective randomized double-blind placebo-controlled trial of plerixafor plus granulocyte colony-stimulating factor compared with placebo plus granulocyte colony-stimulating factor for autologous stem-cell mobilization and transplantation for patients with non-Hodgkin's lymphoma. J Clin Oncol. 2009 Oct 1;27(28):4767-73. doi: 10.1200/JCO.2008.20.7209. Epub 2009 Aug 31.
PMID: 19720922
citation: Flomenberg N, Comenzo RL, Badel K, Calandra G. Plerixafor (Mozobil) alone to mobilize hematopoietic stem cells from multiple myeloma patients for autologous transplantation. Biol Blood Marrow Transplant. 2010 May;16(5):695-700. doi: 10.1016/j.bbmt.2009.12.538. Epub 2010 Jan 11.
PMID: 20067838
citation: Brave M, Farrell A, Ching Lin S, Ocheltree T, Pope Miksinski S, Lee SL, Saber H, Fourie J, Tornoe C, Booth B, Yuan W, He K, Justice R, Pazdur R. FDA review summary: Mozobil in combination with granulocyte colony-stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation. Oncology. 2010;78(3-4):282-8. doi: 10.1159/000315736. Epub 2010 Jun 8.
PMID: 20530974
citation: Haverkos BM, Huang Y, Elder P, O'Donnell L, Scholl D, Whittaker B, Vasu S, Penza S, Andritsos LA, Devine SM, Jaglowski SM. A single center's experience using four different front line mobilization strategies in lymphoma patients planned to undergo autologous hematopoietic cell transplantation. Bone Marrow Transplant. 2017 Apr;52(4):561-566. doi: 10.1038/bmt.2016.304. Epub 2017 Jan 9.
PMID: 28067870
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitario Dr. Jose E. Gonzalez
investigator full name: David Gomez Almaguer
investigator title: Hematology division chief
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
mesh term: Hodgkin Disease
mesh term: Plerixafor