<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/NCT03040401</url>
  </required_header>
  <id_info>
    <org_study_id>NMDSG14A</org_study_id>
    <nct_id>NCT03040401</nct_id>
  </id_info>
  <brief_title>A Study of HDC/IL-2 Treatment in Chronic Myelomonocytic Leukemia (CMML)</brief_title>
  <official_title>A Phase I/II, Open-Label, Multicenter Study of the Safety, Efficacy and Immune Response of Histamine Dihydrochloride and Low-dose Interleukin-2 in Chronic Myelomonocytic Leukemia (CMML)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vastra Gotaland Region</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sahlgrenska University Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Karolinska University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nordic MDS Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vastra Gotaland Region</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Enrolled subjects will receive histamine dihydrochloride (HDC; Ceplene®) and/or IL-2&#xD;
      (Proleukin®) subcutaneously (s.c.) twice daily (BID) in 3-week periods followed by 3- or 6&#xD;
      week rest periods.&#xD;
&#xD;
      All subjects will be assigned to one of three consecutive cohorts, each comprising five&#xD;
      patients.&#xD;
&#xD;
      Cohort 1 will receive HDC without IL-2 for the first treatment cycle, to enable the&#xD;
      assessment of short-term impact of HDC alone on clonal and immunological markers. For all&#xD;
      remaining cycles the combination of HDC and IL-2 will be given.&#xD;
&#xD;
      Cohort 2 will receive the combination of Ceplene and Proleukin in all cycles. After all&#xD;
      patients in cohorts 1 and 2 have completed 4 treatment cycles, immunological and clinical&#xD;
      response and toxicity will be evaluated. On the basis of the results for the first 4 cycles&#xD;
      of cohorts 1 and 2, a third cohort of 5 patients will be enrolled receiving either the&#xD;
      combination of HDC/IL-2 or HDC alone.&#xD;
&#xD;
      In case of a beneficial response* after 4 cycles, treatment may be continued to a total of 10&#xD;
      cycles. Treatment cycles 5-10 will comprise 3 weeks of treatment and 6-week rest periods.&#xD;
&#xD;
      IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during&#xD;
      treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2. The patient or a&#xD;
      family member/significant other will be instructed to administer injections of both study&#xD;
      drugs to allow safe treatment at home.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 15, 2017</start_date>
  <completion_date type="Anticipated">December 15, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2018</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>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse events as defined by CTCAE v4.03.</measure>
    <time_frame>3 weeks after last treatment cycle</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease progression according to IWG criteria for MDS/MPN</measure>
    <time_frame>3 weeks after last treatment cycle</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of blasts in peripheral blood</measure>
    <time_frame>3 weeks after last treatment cycle</time_frame>
    <description>Percentage of blasts (CD34+ cells and promonocytes) will be assessed by flow cytometry. End-of-treatment percentage will be compared to values pre-study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of monocytes in peripheral blood</measure>
    <time_frame>3 weeks after last treatment cycle</time_frame>
    <description>Percentage of CD14+ monocytes will be assessed by flow cytometry. End-of-treatment percentage will be compared to values pre-study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of treated patients that transform to AML</measure>
    <time_frame>2 years after last treatment cycle</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of circulating NK cells i peripheral blood</measure>
    <time_frame>3 weeks after last treatment cycle</time_frame>
    <description>Percentage of NK cells in peripheral blood will be assessed by flow cytometry. End-of-treatment percentage will be compared to values pre-study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of circulating CD4+ T cells i peripheral blood</measure>
    <time_frame>3 weeks after last treatment cycle</time_frame>
    <description>Percentage of CD4+ T cells in peripheral blood will be assessed by flow cytometry. End-of-treatment percentage will be compared to values pre-study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of circulating CD8+ T cells i peripheral blood</measure>
    <time_frame>3 weeks after last treatment cycle</time_frame>
    <description>Percentage of CD8+ T cells in peripheral blood will be assessed by flow cytometry. End-of-treatment percentage will be compared to values pre-study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with overall survival at 2 years.</measure>
    <time_frame>2 years after last treatment cycle</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Leukemia, Myelomonocytic, Chronic</condition>
  <arm_group>
    <arm_group_label>Cohort 1: Ceplene® and Proleukin®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enrolled subjects will receive histamine dihydrochloride (HDC; Ceplene®) and IL-2 (Proleukin®) subcutaneously (s.c.) twice daily (BID) in 3-week periods followed by 3 week rest periods for a total of 4 treatment cycles.&#xD;
IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2 injections.&#xD;
Cohort 1 will receive only Ceplene® during the first treatment cycles and Ceplene® in combination with Proleukin® during treatment cycles 2-4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: Ceplene® and Proleukin®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enrolled subjects will receive histamine dihydrochloride (HDC; Ceplene®) and IL-2 (Proleukin®) subcutaneously (s.c.) twice daily (BID) in 3-week periods followed by 3 week rest periods for a total of 4 treatment cycles.&#xD;
IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2 injections.&#xD;
Cohort 2 will receive Ceplene® in combination with Proleukin® during all treatment cycles (1-4).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3: Ceplene® and Proleukin®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enrolled subjects will receive histamine dihydrochloride (HDC; Ceplene®) and IL-2 (Proleukin®) subcutaneously (s.c.) twice daily (BID) in 3-week periods followed by 3 week rest periods for a total of 4 treatment cycles.&#xD;
IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2 injections.&#xD;
Cohort 3 will receive either only Ceplene® during treatment cycles 1-4 or Ceplene® in combination with Proleukin® during treatment cycles 1-4. Treatment will be decided by the study committee based on the safety profile of treatment administered to cohort 1 and 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cohort 1, Ceplene® and Proleukin®</intervention_name>
    <description>Patients in Cohort 1 will be administered only Ceplene® during the first treatment cycles and Ceplene® in combination with Proleukin® during treatment cycles 2-4.&#xD;
IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2.</description>
    <arm_group_label>Cohort 1: Ceplene® and Proleukin®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cohort 2, Ceplene® and Proleukin®</intervention_name>
    <description>Patients in Cohort 2 will be administered Ceplene® in combination with Proleukin® during all treatment cycles 1-4.&#xD;
IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2.</description>
    <arm_group_label>Cohort 2: Ceplene® and Proleukin®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cohort 3, Ceplene® and Proleukin®</intervention_name>
    <description>Cohort 3 will receive either only Ceplene® during treatment cycles 1-4 or Ceplene® in combination with Proleukin® during treatment cycles 1-4. Treatment will be decided by the study committee based on the safety profile of treatment administered to cohort 1 and 2.&#xD;
IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2.</description>
    <arm_group_label>Cohort 3: Ceplene® and Proleukin®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years of age at the time of signing the informed consent form.&#xD;
&#xD;
          -  CMML-1 with indication for treatment according to NMDSG guidelines*.&#xD;
&#xD;
          -  Life expectancy of more than three months and ability to undergo routine outpatient&#xD;
             evaluations for efficacy, safety, and compliance.&#xD;
&#xD;
          -  The patient must be informed of the investigational nature of the study and written&#xD;
             informed consent obtained and signed.&#xD;
&#xD;
               -  including, but not limited to increasing WBC, transfusion dependence, B-symptoms,&#xD;
                  splenomegaly.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute myeloid leukemia.&#xD;
&#xD;
          -  CMML-2 according to WHO criteria.&#xD;
&#xD;
          -  Systemic mastocytosis.&#xD;
&#xD;
          -  Previous or intended allogeneic stem cell transplantation.&#xD;
&#xD;
          -  Concomitant or intended cytostatic or cytoreductive therapy other than hydroxyurea&#xD;
             (HU) *.&#xD;
&#xD;
          -  ECOG performance status ≥3.&#xD;
&#xD;
          -  Platelet count (TPK) &lt;30x109/L&#xD;
&#xD;
          -  NYHA class III or IV cardiac disease, hypotension or severe hypertension, vasomotor&#xD;
             instability, serious or uncontrolled cardiac dysrhythmias (including ventricular&#xD;
             arrhythmias) at any time, acute myocardial infarction within the past 12 months,&#xD;
             angina pectoris or symptomatic arteriosclerotic blood vessel disease.&#xD;
&#xD;
          -  Other active malignancies except in situ carcinoma of the cervix, localized squamous&#xD;
             or basal cell carcinoma of the skin.&#xD;
&#xD;
          -  Serious concurrent or recent non-malignant medical conditions which, in the opinion of&#xD;
             the Investigator, makes the patient unsuitable for participation in this study.&#xD;
&#xD;
          -  History of seizures, central nervous system disorders, stroke within the last 12&#xD;
             months, or psychiatric disability thought to be clinically significant in the opinion&#xD;
             of the Investigator and adversely affecting compliance to protocol.&#xD;
&#xD;
          -  Serum creatinine &gt; 1.5 times the upper normal limit.&#xD;
&#xD;
          -  Serum aminotransferase (AST), alanine transaminase (ALT) and bilirubin &gt;2.0 times the&#xD;
             upper normal limit&#xD;
&#xD;
          -  Active autoimmune disease (including but not limited to systemic lupus, inflammatory&#xD;
             bowel disease, and psoriasis).&#xD;
&#xD;
          -  Patients with active peptic or esophageal ulcer disease or with past peptic ulcer or&#xD;
             esophageal disease with a history or bleeding.&#xD;
&#xD;
          -  Patients requiring active treatment for hypotension.&#xD;
&#xD;
          -  Patients continuing systemic treatment with clonidine, steroids, and/or H2 receptor&#xD;
             blocking agents.&#xD;
&#xD;
          -  Patients with a history of histamine hypersensitivity, severe allergies to food or&#xD;
             contrast media requiring treatment within the last five years.&#xD;
&#xD;
          -  Pregnancy. Women of childbearing potential (WCBP) and males having intercourse with&#xD;
             WCBP must agree to comply with using an effective contraceptive method for the&#xD;
             duration of the treatment (WCBP is a sexually mature woman who is not surgically&#xD;
             sterile or has not been naturally postmenopausal for at least 12 consecutive months).&#xD;
&#xD;
          -  Nursing&#xD;
&#xD;
               -  Note that treatment with HU is allowed if treatment has been ongoing for at least&#xD;
                  3 months prior to enrollment. The use of HU is also allowed to control&#xD;
                  myeloproliferation after starting study treatment, preferably during resting&#xD;
                  periods.&#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>Lars Möllgård, PhD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sahlgrenska University Hospital, Sweden</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lars Möllgård, PhD, MD</last_name>
    <phone>+46 (0)31 3427344</phone>
    <email>lars.mollgard@vgregion.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Johan Aurelius, PhD</last_name>
    <phone>+46 (0)31 7866677</phone>
    <email>johan.aurelius@gu.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sahlgrenska University Hospital</name>
      <address>
        <city>Gothenburg</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lars Möllgård, PhD, MD</last_name>
      <phone>+46 (0)31 3427344</phone>
      <email>lars.mollgard@vgregion.se</email>
    </contact>
    <contact_backup>
      <last_name>Olle Werlenius, PhD, MD</last_name>
      <email>olle.werlenius@vgregion.se</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Karolinska University Hospital, Huddinge</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Per Broliden, MD, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>December 18, 2017</last_update_submitted>
  <last_update_submitted_qc>December 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CMML</keyword>
  <keyword>Ceplene</keyword>
  <keyword>Interleukin-2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myelomonocytic, Chronic</mesh_term>
    <mesh_term>Leukemia, Myelomonocytic, Juvenile</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aldesleukin</mesh_term>
    <mesh_term>Interleukin-2</mesh_term>
    <mesh_term>Histamine</mesh_term>
    <mesh_term>Histamine phosphate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03040401
org study id: NMDSG14A
nct id: NCT03040401
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Enrolled subjects will receive histamine dihydrochloride (HDC; Ceplene®) and/or IL-2
      (Proleukin®) subcutaneously (s.c.) twice daily (BID) in 3-week periods followed by 3- or 6
      week rest periods.

      All subjects will be assigned to one of three consecutive cohorts, each comprising five
      patients.

      Cohort 1 will receive HDC without IL-2 for the first treatment cycle, to enable the
      assessment of short-term impact of HDC alone on clonal and immunological markers. For all
      remaining cycles the combination of HDC and IL-2 will be given.

      Cohort 2 will receive the combination of Ceplene and Proleukin in all cycles. After all
      patients in cohorts 1 and 2 have completed 4 treatment cycles, immunological and clinical
      response and toxicity will be evaluated. On the basis of the results for the first 4 cycles
      of cohorts 1 and 2, a third cohort of 5 patients will be enrolled receiving either the
      combination of HDC/IL-2 or HDC alone.

      In case of a beneficial response* after 4 cycles, treatment may be continued to a total of 10
      cycles. Treatment cycles 5-10 will comprise 3 weeks of treatment and 6-week rest periods.

      IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during
      treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2. The patient or a
      family member/significant other will be instructed to administer injections of both study
      drugs to allow safe treatment at home.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse events as defined by CTCAE v4.03.
time frame: 3 weeks after last treatment cycle
measure: Disease progression according to IWG criteria for MDS/MPN
time frame: 3 weeks after last treatment cycle
measure: Percentage of blasts in peripheral blood
time frame: 3 weeks after last treatment cycle
description: Percentage of blasts (CD34+ cells and promonocytes) will be assessed by flow cytometry. End-of-treatment percentage will be compared to values pre-study.
measure: Percentage of monocytes in peripheral blood
time frame: 3 weeks after last treatment cycle
description: Percentage of CD14+ monocytes will be assessed by flow cytometry. End-of-treatment percentage will be compared to values pre-study.
measure: Number of treated patients that transform to AML
time frame: 2 years after last treatment cycle
measure: Percentage of circulating NK cells i peripheral blood
time frame: 3 weeks after last treatment cycle
description: Percentage of NK cells in peripheral blood will be assessed by flow cytometry. End-of-treatment percentage will be compared to values pre-study.
measure: Percentage of circulating CD4+ T cells i peripheral blood
time frame: 3 weeks after last treatment cycle
description: Percentage of CD4+ T cells in peripheral blood will be assessed by flow cytometry. End-of-treatment percentage will be compared to values pre-study.
measure: Percentage of circulating CD8+ T cells i peripheral blood
time frame: 3 weeks after last treatment cycle
description: Percentage of CD8+ T cells in peripheral blood will be assessed by flow cytometry. End-of-treatment percentage will be compared to values pre-study.
measure: Proportion of participants with overall survival at 2 years.
time frame: 2 years after last treatment cycle
arm group label: Cohort 1: Ceplene® and Proleukin®
arm group type: Experimental
description: Enrolled subjects will receive histamine dihydrochloride (HDC; Ceplene®) and IL-2 (Proleukin®) subcutaneously (s.c.) twice daily (BID) in 3-week periods followed by 3 week rest periods for a total of 4 treatment cycles.
IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2 injections.
Cohort 1 will receive only Ceplene® during the first treatment cycles and Ceplene® in combination with Proleukin® during treatment cycles 2-4.
arm group label: Cohort 2: Ceplene® and Proleukin®
arm group type: Experimental
description: Enrolled subjects will receive histamine dihydrochloride (HDC; Ceplene®) and IL-2 (Proleukin®) subcutaneously (s.c.) twice daily (BID) in 3-week periods followed by 3 week rest periods for a total of 4 treatment cycles.
IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2 injections.
Cohort 2 will receive Ceplene® in combination with Proleukin® during all treatment cycles (1-4).
arm group label: Cohort 3: Ceplene® and Proleukin®
arm group type: Experimental
description: Enrolled subjects will receive histamine dihydrochloride (HDC; Ceplene®) and IL-2 (Proleukin®) subcutaneously (s.c.) twice daily (BID) in 3-week periods followed by 3 week rest periods for a total of 4 treatment cycles.
IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2 injections.
Cohort 3 will receive either only Ceplene® during treatment cycles 1-4 or Ceplene® in combination with Proleukin® during treatment cycles 1-4. Treatment will be decided by the study committee based on the safety profile of treatment administered to cohort 1 and 2.
intervention type: Drug
intervention name: Cohort 1, Ceplene® and Proleukin®
description: Patients in Cohort 1 will be administered only Ceplene® during the first treatment cycles and Ceplene® in combination with Proleukin® during treatment cycles 2-4.
IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2.
arm group label: Cohort 1: Ceplene® and Proleukin®
intervention type: Drug
intervention name: Cohort 2, Ceplene® and Proleukin®
description: Patients in Cohort 2 will be administered Ceplene® in combination with Proleukin® during all treatment cycles 1-4.
IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2.
arm group label: Cohort 2: Ceplene® and Proleukin®
intervention type: Drug
intervention name: Cohort 3, Ceplene® and Proleukin®
description: Cohort 3 will receive either only Ceplene® during treatment cycles 1-4 or Ceplene® in combination with Proleukin® during treatment cycles 1-4. Treatment will be decided by the study committee based on the safety profile of treatment administered to cohort 1 and 2.
IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2.
arm group label: Cohort 3: Ceplene® and Proleukin®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lars Möllgård, PhD, MD
role: Principal Investigator
affiliation: Sahlgrenska University Hospital, Sweden
last name: Lars Möllgård, PhD, MD
phone: +46 (0)31 3427344
email: lars.mollgard@vgregion.se
last name: Johan Aurelius, PhD
phone: +46 (0)31 7866677
email: johan.aurelius@gu.se
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
country: Sweden
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myelomonocytic, Chronic
mesh term: Leukemia, Myelomonocytic, Juvenile
mesh term: Aldesleukin
mesh term: Interleukin-2
mesh term: Histamine
mesh term: Histamine phosphate
sharing ipd: No